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Efficacy and Safety of Ofatumumab Retreatment and Maintenance Treatment in Patients With B-cell Chronic Lymphocytic Leukemia (CLL)

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ClinicalTrials.gov Identifier: NCT00802737
Recruitment Status : Completed
First Posted : December 5, 2008
Results First Posted : June 26, 2012
Last Update Posted : May 14, 2014
Sponsor:
Collaborator:
Genmab
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Leukaemia, Lymphocytic, Chronic
Intervention Drug: Ofatumumab
Enrollment 29
Recruitment Details Per study protocol
Pre-assignment Details Completed study Hx-CD20-406 (Study OMB111773; NCT00349349)
Arm/Group Title 2000 mg Ofatumumab + DR 2000 mg Ofatumumab + BFR 2000 mg Ofatumumab + Other
Hide Arm/Group Description Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62). Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62). Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as "other," defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
Period Title: Overall Study
Started 17 11 1
Completed 0 0 0
Not Completed 17 11 1
Reason Not Completed
Withdrawn due to Disease Progression             9             3             0
Death             6             5             1
Adverse Event             1             0             0
Received Prohibited Therapy             1             0             0
Ongoing CLL-Treatment             0             1             0
Participant too Unwell             0             2             0
Arm/Group Title 2000 mg Ofatumumab + DR 2000 mg Ofatumumab + BFR 2000 mg Ofatumumab + Other Total
Hide Arm/Group Description Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62). Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62). Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as "other," defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62). Total of all reporting groups
Overall Number of Baseline Participants 17 11 1 29
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants 11 participants 1 participants 29 participants
64.8  (5.83) 66.9  (9.08) 84.0 [1]   (NA) 66.3  (7.85)
[1]
A standard deviation of the mean was not calculated for one participant.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 11 participants 1 participants 29 participants
Female
4
  23.5%
4
  36.4%
1
 100.0%
9
  31.0%
Male
13
  76.5%
7
  63.6%
0
   0.0%
20
  69.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 17 participants 11 participants 1 participants 29 participants
Asian 1 0 0 1
White 16 11 1 28
1.Primary Outcome
Title Number of Participants (Par.) Classified as Responders (Rs) and Non-responders (NRs) for Objective Response in Accordance With the National Cancer Institute Working Group (NCIWG) 1996 Guidelines
Hide Description Par. with complete remission (CR), nodular partial remission (nPR), and partial remission (PR) on 2 consecutive visits >=56 days apart were classified as Rs; those with stable disease (SD)/progressive disease (PD) were classified as NRs. Per the NCIWG 1996 guidelines: CR; no lymphadenopathy/hepatomegaly/splenomegaly/constitutional symptoms, normal hematology, normocellular bone marrow sample for age, <30% lymphocytes (LC), no lymphoid nodule; PR: >=50% decrease in LC/lymphadenopathy; nPR: persistent bone marrow nodules; PD: new lesion or increase by >=50% from baseline; SD: no CR, PR, or PD.
Time Frame Start of treatment (Week 0/Visit 2) until Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): all participants who had been exposed to study drug irrespective of their compliance to the planned course of treatment. Some participants were not evaluable (NE) due to participant withdraw, refusal, non-trial drug-related adverse events, and death.
Arm/Group Title 2000 mg Ofatumumab + DR 2000 mg Ofatumumab + BFR 2000 mg Ofatumumab + Other
Hide Arm/Group Description:
Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as "other," defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
Overall Number of Participants Analyzed 17 11 1
Measure Type: Number
Unit of Measure: participants
Responders with CR 2 0 0
Responders with nPR 0 0 0
Responders with PR 2 2 1
Non-responders with SD 8 7 0
Non-responders with PD 3 0 0
NE 2 2 0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2000 mg Ofatumumab + DR
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter proportion of responders
Estimated Value 0.24
Confidence Interval (2-Sided) 95%
0.07 to 0.50
Estimation Comments Two-sided 95% exact confidence intervals were calculated based on the binomial distribution. The estimated value was calculated using the number of responders (CR+nPR+PR) as the numerator and the total number of par. in the group as the denominator.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 2000 mg Ofatumumab + BFR
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter proportion of responders
Estimated Value 0.18
Confidence Interval (2-Sided) 95%
0.02 to 0.52
Estimation Comments Two-sided 95% exact confidence intervals were calculated based on the binomial distribution. The estimated value was calculated using the number of responders (CR+nPR+PR) as the numerator and the total number of par. in the group as the denominator.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 2000 mg Ofatumumab + Other
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter proportion of responders
Estimated Value 1.00
Confidence Interval (2-Sided) 95%
0.03 to 1.00
Estimation Comments Two-sided 95% exact confidence intervals were calculated based on the binomial distribution. The estimated value was calculated using the number of responders (CR+nPR+PR) as the numerator and the total number of par. in the group as the denominator.
2.Secondary Outcome
Title Duration of Response
Hide Description Duration of response is defined as the time from the initial response (first visit at which response is observed) to progression or death. If the participant had progression between scheduled visits, no progression at the end of the trial, treatment discontinuation for undocumented progression, treatment discontinuation for toxicity or other reason, new anti-cancer treatment, and experienced death or progression after two or more missed visits in a row the endpoint was censored.
Time Frame From the time of the initial response until progression or death (average of 14.1 study months)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title 2000 mg Ofatumumab + DR 2000 mg Ofatumumab + BFR 2000 mg Ofatumumab + Other
Hide Arm/Group Description:
Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as "other," defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
Overall Number of Participants Analyzed 17 11 1
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(7.2 to NA)
NA [2] 
(24.1 to NA)
NA [3] 
(NA to NA)
[1]
There were not enough events on the survival curve to estimate a median or upper limit of confidence interval.
[2]
There were not enough events on the survival curve to estimate a median or upper limit of confidence interval
[3]
There were not enough events on the survival curve to estimate a median or confidence interval.
3.Secondary Outcome
Title Progression-Free Survival (PFS)
Hide Description PFS is defined as the time from randomization until progression (prog.)/death. Prog. events are defined by well-documented and verifiable data; other data are censored. If the par. had prog. between scheduled visits, died before the first assessment, or died between adequate visits, the endpoint was considered progressed. If there was no prog. at the end of the trial, treatment discontinuation for undocumented prog./toxicity/other reason, new anti-cancer treatment, and death/prog. after >=2 missed visits in a row, the endpoint was censored. Clinical prog. is not considered as a prog. endpoint.
Time Frame Start of treatment (Week 0 of Visit 2) until progression or death (average of 14.1 study months)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title 2000 mg Ofatumumab + DR 2000 mg Ofatumumab + BFR 2000 mg Ofatumumab + Other
Hide Arm/Group Description:
Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as "other," defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
Overall Number of Participants Analyzed 17 11 1
Median (95% Confidence Interval)
Unit of Measure: months
7.9
(3.2 to 12.9)
7.2
(2.0 to 11.6)
NA [1] 
(NA to NA)
[1]
There were not enough events on the survival curve to estimate a median or confidence interval.
4.Secondary Outcome
Title Time to Next Chronic Lymphocytic Leukemia (CLL) Treatment
Hide Description Time to next chronic lymphocytic leukemia (CLL) treatment is defined as the time from treatment allocation/randomization (Visit 2) until the time of the first administration of the next CLL treatment other than ofatumumab (or HuMaxCD20, a fully human monoclonal antibody to CD20 that is expressed on the surface of B-cells).
Time Frame Time from start of study treatment (Week 0 of Visit 2) until the time of first administration of a CLL treatment other than ofatumumab (average of 14.8 study months)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title 2000 mg Ofatumumab + DR 2000 mg Ofatumumab + BFR 2000 mg Ofatumumab + Other
Hide Arm/Group Description:
Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as "other," defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
Overall Number of Participants Analyzed 17 11 1
Median (95% Confidence Interval)
Unit of Measure: months
13.9 [1] 
(3.9 to NA)
11.6 [1] 
(7.0 to NA)
NA [2] 
(NA to NA)
[1]
There were not enough events on the survival curve to estimate the upper limit of the confidence interval.
[2]
There were not enough events on the survival curve to estimate a median or confidence interval.
5.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS is defined as the time from allocation to death.
Time Frame Time from start of study treatment (Week 0 of Visit 2) until date of death or time that participant was no longer followed (median of 18.0 months)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title 2000 mg Ofatumumab + DR 2000 mg Ofatumumab + BFR 2000 mg Ofatumumab + Other
Hide Arm/Group Description:
Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as "other," defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
Overall Number of Participants Analyzed 17 11 1
Median (95% Confidence Interval)
Unit of Measure: months
27.6 [1] 
(5.4 to NA)
11.3 [1] 
(5.3 to NA)
12.3 [2] 
(NA to NA)
[1]
There were not enough events on the survival curve to estimate the upper limit of the confidence interval.
[2]
There were not enough events on the survival curve to estimate a confidence interval.
6.Secondary Outcome
Title Median Percent Change of Tumor Size (Sum of Products Dimensions [SPD]) From Baseline (Visit 2) at Month 4
Hide Description Reduction in tumor size was measured as the percent change in the sum of the products of the diameters of the largest abnormal lymph nodes from Baseline to Week 24. Percent change was calculated as (Week 24 SPD minus Baseline SPD)/Baseline SPD * 100.
Time Frame Baseline (Visit 2) and Month 4
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Measurement of tumor size was completed by physical examination for participants remaining in the study at Month 4. Only participants with a baseline value and a post-baseline value at Month 4 were included in the calculation.
Arm/Group Title 2000 mg Ofatumumab + DR 2000 mg Ofatumumab + BFR 2000 mg Ofatumumab + Other
Hide Arm/Group Description:
Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as "other," defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
Overall Number of Participants Analyzed 8 6 1
Median (Full Range)
Unit of Measure: Percent change in tumor size
-55.3
(-100 to 157)
-64.8
(-82 to 3)
0
(0 to 0)
7.Secondary Outcome
Title Median Percent Change of Tumor Size (Sum of Products Dimensions [SPD]) From Baseline (Visit 2) at Month 12
Hide Description Reduction in tumor size was measured by the percentage change in the sum of products of the diameters of the largest abnormal lymph nodes from Baseline to Month 12. Percent change was calculated as (Month 12 SPD minus Baseline SPD)/Baseline SPD * 100.
Time Frame Baseline (Visit 2) and Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. No participants in the 2000 mg Ofatumumab + Other treatment arm were able to contribute to this measure. Measurement of tumor size was completed by physical examination for participants remaining in the study at Month 12. Only participants with a baseline value and a post-baseline value at Month 12 were included in the calculation.
Arm/Group Title 2000 mg Ofatumumab + DR 2000 mg Ofatumumab + BFR 2000 mg Ofatumumab + Other
Hide Arm/Group Description:
Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as "other," defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
Overall Number of Participants Analyzed 4 1 0
Median (Full Range)
Unit of Measure: Percent change in tumor size
-65.2
(-100 to 0)
-68.9
(-68.9 to -68.9)
8.Secondary Outcome
Title Median Percent Change of Tumor Size (Sum of Products Dimensions [SPD]) From Baseline (Visit 2) at Month 24
Hide Description Reduction in tumor size was measured by the percentage change in the sum of products of the diameters of the largest abnormal lymph nodes from Baseline to Month 24. Percent change was calculated as (Month 24 SPD minus Baseline SPD)/Baseline SPD * 100.
Time Frame Baseline (Visit 2) and Month 24
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Hide Analysis Population Description
FAS. No participants in the 2000 mg Ofatumumab + Other treatment arm were able to contribute to this measure. Measurement of tumor size was completed by physical examination for participants remaining in the study at Month 24. Only participants with a baseline value and a post-baseline value at Month 24 were included in the calculation.
Arm/Group Title 2000 mg Ofatumumab + DR 2000 mg Ofatumumab + BFR 2000 mg Ofatumumab + Other
Hide Arm/Group Description:
Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as "other," defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
Overall Number of Participants Analyzed 2 1 0
Median (Full Range)
Unit of Measure: Percent change in tumor size
-83.3
(-100 to -67)
-64.0
(-64 to -64)
9.Secondary Outcome
Title Number of Participants With Negative and Positive Human Anti-human Antibody (HAHA) Results at the Time of Screening and Post Ofatumumab
Hide Description HAHAs are indicators of immunogenicity to ofatumumab. HAHA levels were assessed for each participant at the end of participation in the study (at their last visit). A positive HAHA status indicates a positive enzyme-linked immunosorbent assay (ELISA) result, an inconclusive status indicates a negative ELISA result at ofatumumab concentration above the threshold at which ofatumumab may interfere with the assay, and a negative status indicates a negative ELISA result at ofatumumab concentration below the threshold.
Time Frame Screening and post ofatumumab (up to Study Month 32)
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Hide Analysis Population Description
FAS. During the study, samples were to be taken at the last visit; however, this may not have been possible, such as in cases of death, or when the visit was not obvious as the "last visit." Therefore, some samples were not available or were not collected.
Arm/Group Title 2000 mg Ofatumumab + DR 2000 mg Ofatumumab + BFR 2000 mg Ofatumumab + Other Total
Hide Arm/Group Description:
Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as "other," defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
This arm includes a total of all three arms combined.
Overall Number of Participants Analyzed 17 11 1 29
Measure Type: Number
Unit of Measure: participants
Screening, Positive, n=15 , 11, 1, 27 0 0 0 0
Screening, Inconclusive, n = 15 , 11 , 1, 27 5 6 0 11
Screening, Negative, n = 15 , 11 , 1, 27 10 5 1 16
Post-ofatumumab, Positive, n = 12 , 8 , 1, 21 0 0 0 0
Post-ofatumumab, Inconclusive, n=12 , 8, 1, 21 9 8 1 18
Post-ofatumumab, Negative, n =12 , 8, 1 , 21 3 0 0 3
10.Secondary Outcome
Title Number of Participants Who Experienced Any Adverse Event
Hide Description An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with the treatment. A list of AEs experienced in the study with a frequency threshold of 5% can be found in the AE section of this results record.
Time Frame From the first infusion (Visit 2/Week 0) until the last visit of the Extended Follow-up Phase (up to Study Month 26 [visit 34])
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Hide Analysis Population Description
FAS
Arm/Group Title 2000 mg Ofatumumab + DR 2000 mg Ofatumumab + BFR 2000 mg Ofatumumab + Other
Hide Arm/Group Description:
Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as "other," defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
Overall Number of Participants Analyzed 17 11 1
Measure Type: Number
Unit of Measure: participants
15 11 1
11.Secondary Outcome
Title Number of Participants With the Indicated Major Infections
Hide Description The data collected for this analysis are reported in the overall Serious Adverse Events (SAEs) of infections rather than reported separately for this specific analysis. This is a conservative approach for reporting all infectious SAEs in order to ensure that all of the infectious SAEs are represented.
Time Frame From the first infusion (Visit 2/Week 0) until the last visit of the Extended Follow-up Phase (up to Study Month 26 [visit 34])
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Hide Analysis Population Description
FAS
Arm/Group Title 2000 mg Ofatumumab + DR 2000 mg Ofatumumab + BFR 2000 mg Ofatumumab + Other
Hide Arm/Group Description:
Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as "other," defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Number of Participants With Infections Requiring Hospitalization or Intravenous Antibiotics
Hide Description The data collected for this analysis are reported in the overall SAEs of infections rather than reported separately for this specific analysis. This is a conservative approach for reporting all infectious SAEs in order to ensure that all of the infectious SAEs are represented.
Time Frame From the first infusion (Visit 2/Week 0) until the last visit of the Extended Follow-up Phase (up to Study Month 26 [visit 34])
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title 2000 mg Ofatumumab + DR 2000 mg Ofatumumab + BFR 2000 mg Ofatumumab + Other
Hide Arm/Group Description:
Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as "other," defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
13.Secondary Outcome
Title Cmax and Ctrough at Visit 2 (Week 0) and at Visit 14 (Month 4)
Hide Description Cmax is defined as the maximum concentration of drug in plasma samples (collected at the end of the infusion). Ctrough is defined as the concentration of drug in plasma samples at the end of a dosing interval (collected directly before next administration). Ctrough before the first infusion represents residual ofatumumab from participation in Study Hx-CD20-406.
Time Frame Visit 2 (Week 0) and Visit 14 (Month 4)
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Hide Analysis Population Description
FAS. Data are provided for the number of participants attending each visit. Participants withdrawn during the study were not analyzed.
Arm/Group Title 2000 mg Ofatumumab + DR 2000 mg Ofatumumab + BFR 2000 mg Ofatumumab + Other Total
Hide Arm/Group Description:
Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as "other," defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
This arm includes a total of all three arms combined.
Overall Number of Participants Analyzed 17 11 1 29
Geometric Mean (95% Confidence Interval)
Unit of Measure: Milligrams per liter (mg/L)
Cmax Visit 2, n= 16, 11, 1, 28
54.8
(30.7 to 97.7)
58.8
(38.6 to 89.5)
110 [1] 
(NA to NA)
57.7
(40.7 to 82.0)
Cmax Visit 14, n= 8, 5, 0, 13
617
(413 to 922)
708
(352 to 1424)
NA [2] 
(NA to NA)
651
(482 to 877)
Ctrough Visit 2, n= 16, 11, 1, 28
1.1
(0.32 to 4.0)
2.8
(1.1 to 7.5)
0.0 [1] 
(NA to NA)
1.7
(0.77 to 3.6)
Ctrough Visit 14, n= 8, 5, 0, 13
42.6
(6.4 to 285)
59.5
(4.7 to 757)
NA [2] 
(NA to NA)
48.5
(13.6 to 173)
[1]
The 95% CI could not be calculated due to the sample size (n=1).
[2]
Participants in group Ofatumumab + Other did not have a sample collection at Visit 14.
Time Frame On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the first dose of investigational product until the last visit of the Extended Follow-up Phase (up to Study Month 26 [visit 34]).
Adverse Event Reporting Description SAEs and non-serious AEs were reported for members of the Safety Population, comprised of all participants randomized to treatment who received >=1 dose of trial medication.
 
Arm/Group Title 2000 mg Ofatumumab + DR 2000 mg Ofatumumab + BFR 2000 mg Ofatumumab + Other
Hide Arm/Group Description Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62). Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62). Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as "other," defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
All-Cause Mortality
2000 mg Ofatumumab + DR 2000 mg Ofatumumab + BFR 2000 mg Ofatumumab + Other
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
2000 mg Ofatumumab + DR 2000 mg Ofatumumab + BFR 2000 mg Ofatumumab + Other
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   11/17 (64.71%)   10/11 (90.91%)   1/1 (100.00%) 
Blood and lymphatic system disorders       
Neutropenia † 1  3/17 (17.65%)  0/11 (0.00%)  0/1 (0.00%) 
Haemolytic anaemia † 1  0/17 (0.00%)  1/11 (9.09%)  0/1 (0.00%) 
Lymphadenopathy † 1  1/17 (5.88%)  0/11 (0.00%)  0/1 (0.00%) 
Cardiac disorders       
Atrial fibrillation † 1  1/17 (5.88%)  0/11 (0.00%)  0/1 (0.00%) 
Gastrointestinal disorders       
Enteritis † 1  1/17 (5.88%)  0/11 (0.00%)  0/1 (0.00%) 
Diarrhea † 1  1/17 (5.88%)  1/11 (9.09%)  0/1 (0.00%) 
Inguinal hernia † 1  0/17 (0.00%)  1/11 (9.09%)  0/1 (0.00%) 
General disorders       
Disease progression † 1  2/17 (11.76%)  1/11 (9.09%)  1/1 (100.00%) 
Pyrexia † 1  1/17 (5.88%)  1/11 (9.09%)  0/1 (0.00%) 
Death † 1  0/17 (0.00%)  1/11 (9.09%)  0/1 (0.00%) 
Infections and infestations       
Bronchopneumonia † 1  2/17 (11.76%)  1/11 (9.09%)  0/1 (0.00%) 
Pneumonia † 1  1/17 (5.88%)  2/11 (18.18%)  0/1 (0.00%) 
Candida pneumonia † 1  1/17 (5.88%)  0/11 (0.00%)  0/1 (0.00%) 
Herpes zoster † 1  0/17 (0.00%)  1/11 (9.09%)  0/1 (0.00%) 
Infection † 1  1/17 (5.88%)  0/11 (0.00%)  0/1 (0.00%) 
Lung infection pseudomonal † 1  0/17 (0.00%)  1/11 (9.09%)  0/1 (0.00%) 
Pneumocystis jiroveci pneumonia † 1  0/17 (0.00%)  1/11 (9.09%)  0/1 (0.00%) 
Rhinitis † 1  1/17 (5.88%)  0/11 (0.00%)  0/1 (0.00%) 
Sepsis † 1  0/17 (0.00%)  1/11 (9.09%)  0/1 (0.00%) 
Upper respiratory tract infection † 1  1/17 (5.88%)  0/11 (0.00%)  0/1 (0.00%) 
Urinary tract infection † 1  0/17 (0.00%)  0/11 (0.00%)  1/1 (100.00%) 
Infection Respiratory tract infection † 1  1/17 (5.88%)  0/11 (0.00%)  0/1 (0.00%) 
Respiratory tract infection fungal † 1  1/17 (5.88%)  0/11 (0.00%)  0/1 (0.00%) 
Injury, poisoning and procedural complications       
Femoral neck fracture † 1  0/17 (0.00%)  1/11 (9.09%)  0/1 (0.00%) 
Investigations       
Weight decreased † 1  1/17 (5.88%)  0/11 (0.00%)  0/1 (0.00%) 
Metabolism and nutrition disorders       
Dehydration † 1  0/17 (0.00%)  1/11 (9.09%)  0/1 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Chronic lympocytic leukaemia † 1  0/17 (0.00%)  1/11 (9.09%)  0/1 (0.00%) 
Chronic lymphocytic leukaemia refractory † 1  0/17 (0.00%)  1/11 (9.09%)  0/1 (0.00%) 
Melanoma, recurrent † 1  0/17 (0.00%)  1/11 (9.09%)  0/1 (0.00%) 
Malignant neoplasm of pleura † 1  1/17 (5.88%)  0/11 (0.00%)  0/1 (0.00%) 
Renal and urinary disorders       
Renal failure † 1  1/17 (5.88%)  0/11 (0.00%)  0/1 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Bronchiectasis † 1  0/17 (0.00%)  1/11 (9.09%)  0/1 (0.00%) 
Dyspnea † 1  3/17 (17.65%)  0/11 (0.00%)  0/1 (0.00%) 
Skin and subcutaneous tissue disorders       
Rash † 1  0/17 (0.00%)  1/11 (9.09%)  0/1 (0.00%) 
Vascular disorders       
Femoral artery occlusion † 1  1/17 (5.88%)  0/11 (0.00%)  0/1 (0.00%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
2000 mg Ofatumumab + DR 2000 mg Ofatumumab + BFR 2000 mg Ofatumumab + Other
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   15/17 (88.24%)   11/11 (100.00%)   1/1 (100.00%) 
Blood and lymphatic system disorders       
Anaemia † 1  2/17 (11.76%)  1/11 (9.09%)  0/1 (0.00%) 
Lymphopenia † 1  1/17 (5.88%)  0/11 (0.00%)  0/1 (0.00%) 
Splenomegaly † 1  1/17 (5.88%)  0/11 (0.00%)  0/1 (0.00%) 
Thrombocytopenia † 1  1/17 (5.88%)  0/11 (0.00%)  0/1 (0.00%) 
Neutropenia † 1  1/17 (5.88%)  0/11 (0.00%)  0/1 (0.00%) 
Cardiac disorders       
Atrial fibrillation † 1  0/17 (0.00%)  1/11 (9.09%)  0/1 (0.00%) 
Ear and labyrinth disorders       
Vertigo † 1  0/17 (0.00%)  1/11 (9.09%)  0/1 (0.00%) 
Eye disorders       
Conjunctivitis † 1  0/17 (0.00%)  1/11 (9.09%)  1/1 (100.00%) 
Eyelid oedema † 1  0/17 (0.00%)  1/11 (9.09%)  0/1 (0.00%) 
Gastrointestinal disorders       
Diarrhea † 1  4/17 (23.53%)  5/11 (45.45%)  1/1 (100.00%) 
Nausea † 1  5/17 (29.41%)  2/11 (18.18%)  0/1 (0.00%) 
Vomiting † 1  4/17 (23.53%)  2/11 (18.18%)  0/1 (0.00%) 
Abdominal pain † 1  4/17 (23.53%)  1/11 (9.09%)  0/1 (0.00%) 
Constipation † 1  1/17 (5.88%)  3/11 (27.27%)  0/1 (0.00%) 
Abdominal pain upper † 1  1/17 (5.88%)  2/11 (18.18%)  0/1 (0.00%) 
Dyspepsia † 1  1/17 (5.88%)  1/11 (9.09%)  0/1 (0.00%) 
Gingivitis † 1  0/17 (0.00%)  2/11 (18.18%)  0/1 (0.00%) 
Paraesthesia oral † 1  1/17 (5.88%)  1/11 (9.09%)  0/1 (0.00%) 
Abdominal distension † 1  1/17 (5.88%)  0/11 (0.00%)  0/1 (0.00%) 
Dry mouth † 1  0/17 (0.00%)  1/11 (9.09%)  0/1 (0.00%) 
Gastroesophageal reflux disease † 1  1/17 (5.88%)  0/11 (0.00%)  0/1 (0.00%) 
Hiatus hernia † 1  1/17 (5.88%)  0/11 (0.00%)  0/1 (0.00%) 
Mouth ulceration † 1  0/17 (0.00%)  1/11 (9.09%)  0/1 (0.00%) 
Oral pain † 1  1/17 (5.88%)  0/11 (0.00%)  0/1 (0.00%) 
Stomatitis † 1  1/17 (5.88%)  0/11 (0.00%)  0/1 (0.00%) 
Tongue blistering † 1  0/17 (0.00%)  1/11 (9.09%)  0/1 (0.00%) 
General disorders       
Chills † 1  1/17 (5.88%)  4/11 (36.36%)  1/1 (100.00%) 
Pyrexia † 1  4/17 (23.53%)  3/11 (27.27%)  0/1 (0.00%) 
Oedema peripheral † 1  1/17 (5.88%)  3/11 (27.27%)  0/1 (0.00%) 
Chest pain † 1  2/17 (11.76%)  0/11 (0.00%)  0/1 (0.00%) 
Fatigue † 1  0/17 (0.00%)  2/11 (18.18%)  0/1 (0.00%) 
Infusion site extravasation † 1  0/17 (0.00%)  2/11 (18.18%)  0/1 (0.00%) 
Asthenia † 1  0/17 (0.00%)  1/11 (9.09%)  0/1 (0.00%) 
Chest discomfort † 1  0/17 (0.00%)  1/11 (9.09%)  0/1 (0.00%) 
Influenza like illness † 1  0/17 (0.00%)  1/11 (9.09%)  0/1 (0.00%) 
Oedema † 1  1/17 (5.88%)  0/11 (0.00%)  0/1 (0.00%) 
Immune system disorders       
Hypersensitivity † 1  2/17 (11.76%)  0/11 (0.00%)  0/1 (0.00%) 
Allergy to arthropod bite † 1  1/17 (5.88%)  0/11 (0.00%)  0/1 (0.00%) 
Infections and infestations       
Bronchitis † 1  2/17 (11.76%)  1/11 (9.09%)  0/1 (0.00%) 
Furuncle † 1  1/17 (5.88%)  1/11 (9.09%)  0/1 (0.00%) 
Herpes zoster † 1  1/17 (5.88%)  0/11 (0.00%)  1/1 (100.00%) 
Infected bites † 1  2/17 (11.76%)  0/11 (0.00%)  0/1 (0.00%) 
Respiratory tract infection † 1  1/17 (5.88%)  1/11 (9.09%)  0/1 (0.00%) 
Upper respiratory tract infection † 1  1/17 (5.88%)  1/11 (9.09%)  0/1 (0.00%) 
Candidiasis † 1  0/17 (0.00%)  1/11 (9.09%)  0/1 (0.00%) 
Erysipelas † 1  1/17 (5.88%)  0/11 (0.00%)  0/1 (0.00%) 
Fungal infection † 1  0/17 (0.00%)  1/11 (9.09%)  0/1 (0.00%) 
Fungal skin infection † 1  1/17 (5.88%)  0/11 (0.00%)  0/1 (0.00%) 
Influenza † 1  1/17 (5.88%)  0/11 (0.00%)  0/1 (0.00%) 
Lower respiratory tract infection † 1  0/17 (0.00%)  1/11 (9.09%)  0/1 (0.00%) 
Lung infection † 1  0/17 (0.00%)  1/11 (9.09%)  0/1 (0.00%) 
Nasopharyngitis † 1  1/17 (5.88%)  0/11 (0.00%)  0/1 (0.00%) 
Oral herpes † 1  0/17 (0.00%)  1/11 (9.09%)  0/1 (0.00%) 
Rhinitis † 1  1/17 (5.88%)  0/11 (0.00%)  0/1 (0.00%) 
Skin infection † 1  1/17 (5.88%)  0/11 (0.00%)  0/1 (0.00%) 
Urinary tract infection † 1  1/17 (5.88%)  0/11 (0.00%)  0/1 (0.00%) 
Haemophilus infection † 1  1/17 (5.88%)  0/11 (0.00%)  0/1 (0.00%) 
Injury, poisoning and procedural complications       
Contusion † 1  1/17 (5.88%)  0/11 (0.00%)  0/1 (0.00%) 
Humerus fracture † 1  1/17 (5.88%)  0/11 (0.00%)  0/1 (0.00%) 
Muscle strain † 1  1/17 (5.88%)  0/11 (0.00%)  0/1 (0.00%) 
Rib fracture † 1  0/17 (0.00%)  1/11 (9.09%)  0/1 (0.00%) 
Wound † 1  1/17 (5.88%)  0/11 (0.00%)  0/1 (0.00%) 
Investigations       
C-Reactive protein increased † 1  1/17 (5.88%)  1/11 (9.09%)  0/1 (0.00%) 
Alanine aminotransferase increased † 1  1/17 (5.88%)  0/11 (0.00%)  0/1 (0.00%) 
Platelet count decreased † 1  0/17 (0.00%)  1/11 (9.09%)  0/1 (0.00%) 
Reticulocyte count increased † 1  1/17 (5.88%)  0/11 (0.00%)  0/1 (0.00%) 
Weight decreased † 1  1/17 (5.88%)  0/11 (0.00%)  0/1 (0.00%) 
Metabolism and nutrition disorders       
Decreased appetite † 1  2/17 (11.76%)  2/11 (18.18%)  0/1 (0.00%) 
Hypokalaemia † 1  2/17 (11.76%)  2/11 (18.18%)  0/1 (0.00%) 
Cachexia † 1  0/17 (0.00%)  1/11 (9.09%)  1/1 (100.00%) 
Dehydration † 1  1/17 (5.88%)  0/11 (0.00%)  0/1 (0.00%) 
Hyperglycaemia † 1  0/17 (0.00%)  1/11 (9.09%)  0/1 (0.00%) 
Hypocalcaemia † 1  1/17 (5.88%)  0/11 (0.00%)  0/1 (0.00%) 
Hypophosphataemia † 1  1/17 (5.88%)  0/11 (0.00%)  0/1 (0.00%) 
Magnesium deficiency † 1  0/17 (0.00%)  1/11 (9.09%)  0/1 (0.00%) 
Musculoskeletal and connective tissue disorders       
Back pains † 1  3/17 (17.65%)  3/11 (27.27%)  0/1 (0.00%) 
Arthralgia † 1  2/17 (11.76%)  1/11 (9.09%)  0/1 (0.00%) 
Muscle spasms † 1  2/17 (11.76%)  1/11 (9.09%)  0/1 (0.00%) 
Musculoskeletal chest pains † 1  2/17 (11.76%)  0/11 (0.00%)  0/1 (0.00%) 
Musculoskeletal pain † 1  2/17 (11.76%)  0/11 (0.00%)  0/1 (0.00%) 
Pain in extremity † 1  1/17 (5.88%)  1/11 (9.09%)  0/1 (0.00%) 
Joint swelling † 1  1/17 (5.88%)  0/11 (0.00%)  0/1 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Squamous cell carcinoma † 1  0/17 (0.00%)  1/11 (9.09%)  0/1 (0.00%) 
Squamous cell carcinoma of skin † 1  1/17 (5.88%)  0/11 (0.00%)  0/1 (0.00%) 
Basal cell carcinoma † 1  1/17 (5.88%)  0/11 (0.00%)  0/1 (0.00%) 
Nervous system disorders       
Paraesthesia † 1  0/17 (0.00%)  2/11 (18.18%)  0/1 (0.00%) 
Dizziness † 1  1/17 (5.88%)  1/11 (9.09%)  0/1 (0.00%) 
Dizziness postural † 1  0/17 (0.00%)  1/11 (9.09%)  0/1 (0.00%) 
Headache † 1  1/17 (5.88%)  0/11 (0.00%)  0/1 (0.00%) 
Neuralgia † 1  0/17 (0.00%)  1/11 (9.09%)  0/1 (0.00%) 
Psychiatric disorders       
Insomnia † 1  0/17 (0.00%)  1/11 (9.09%)  0/1 (0.00%) 
Anxiety † 1  1/17 (5.88%)  0/11 (0.00%)  0/1 (0.00%) 
Renal and urinary disorders       
Dysuria † 1  1/17 (5.88%)  0/11 (0.00%)  0/1 (0.00%) 
Renal impairment † 1  0/17 (0.00%)  1/11 (9.09%)  0/1 (0.00%) 
Reproductive system and breast disorders       
Vaginal haemorrhage † 1  1/17 (5.88%)  0/11 (0.00%)  0/1 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Cough † 1  3/17 (17.65%)  4/11 (36.36%)  1/1 (100.00%) 
Dyspnoea † 1  1/17 (5.88%)  2/11 (18.18%)  0/1 (0.00%) 
Chronic obstructive pulmonary disease † 1  1/17 (5.88%)  0/11 (0.00%)  0/1 (0.00%) 
Dysphonia † 1  1/17 (5.88%)  0/11 (0.00%)  0/1 (0.00%) 
Dyspnoea exertional † 1  1/17 (5.88%)  0/11 (0.00%)  0/1 (0.00%) 
Oropharyngeal pain † 1  0/17 (0.00%)  1/11 (9.09%)  0/1 (0.00%) 
Productive cough † 1  1/17 (5.88%)  0/11 (0.00%)  0/1 (0.00%) 
Rales † 1  0/17 (0.00%)  1/11 (9.09%)  0/1 (0.00%) 
Rhinorrhoea † 1  0/17 (0.00%)  1/11 (9.09%)  0/1 (0.00%) 
Sneezing † 1  0/17 (0.00%)  1/11 (9.09%)  0/1 (0.00%) 
Nasal polyps † 1  1/17 (5.88%)  0/11 (0.00%)  0/1 (0.00%) 
Upper respiratory tract congestion † 1  1/17 (5.88%)  0/11 (0.00%)  0/1 (0.00%) 
Skin and subcutaneous tissue disorders       
Rash † 1  3/17 (17.65%)  1/11 (9.09%)  0/1 (0.00%) 
Hyperhidrosis † 1  2/17 (11.76%)  1/11 (9.09%)  0/1 (0.00%) 
Blister † 1  0/17 (0.00%)  2/11 (18.18%)  0/1 (0.00%) 
Eczema † 1  1/17 (5.88%)  0/11 (0.00%)  0/1 (0.00%) 
Pruritus † 1  1/17 (5.88%)  0/11 (0.00%)  0/1 (0.00%) 
Actinic keratosis † 1  1/17 (5.88%)  0/11 (0.00%)  0/1 (0.00%) 
Vascular disorders       
Flushing † 1  3/17 (17.65%)  1/11 (9.09%)  0/1 (0.00%) 
Hypotension † 1  1/17 (5.88%)  2/11 (18.18%)  0/1 (0.00%) 
Hypertension † 1  1/17 (5.88%)  1/11 (9.09%)  0/1 (0.00%) 
Hot flush † 1  0/17 (0.00%)  1/11 (9.09%)  0/1 (0.00%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
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Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00802737    
Other Study ID Numbers: 111827
GEN416
First Submitted: December 4, 2008
First Posted: December 5, 2008
Results First Submitted: May 17, 2012
Results First Posted: June 26, 2012
Last Update Posted: May 14, 2014