Ofatumumab for Initial Systemic Treatment of Indolent B-cell Lymphoma

• ClinicalTrials.gov Identifier: NCT01239394
• Recruitment Status: Completed
• First Posted: November 11, 2010
• Results First Posted: March 17, 2017
• Last Update Posted: October 18, 2017
• Sponsor: Massachusetts General Hospital
• Collaborators: Dana-Farber Cancer Institute; Beth Israel Deaconess Medical Center; GlaxoSmithKline
• Information provided by (Responsible Party): Jeremy Abramson, MD, Massachusetts General Hospital

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Conditions: Follicular Lymphoma; Marginal Zone Lymphoma; Small Lymphocytic Lymphoma
• Intervention: Drug: ofatumumab
• Enrollment: 43

Participant Flow

Recruitment Details
Pre-assignment Details	The number enrolled (43) and number starting study (42) do not match because one patient never began study treatment due to an acute stroke prior to any study treatment.

Arm/Group Title	Ofatumumab
Arm/Group Description	single-arm, open-label, interventional ofatumumab: Weekly infusion for 8 weeks
Period Title: Overall Study
Started	42
Completed	41
Not Completed	1
Reason Not Completed
Adverse Event	1

Baseline Characteristics

Arm/Group Title		Ofatumumab
Arm/Group Description		single-arm, open-label, interventional ofatumumab: Weekly infusion for 8 weeks
Overall Number of Baseline Participants		42
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Median (Full Range); Unit of measure: Years
	Number Analyzed	42 participants
		64.4; (33.7 to 91.9)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	42 participants
	Female	18 42.9%
	Male	24 57.1%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	42 participants
	Hispanic or Latino	2 4.8%
	Not Hispanic or Latino	35 83.3%
	Unknown or Not Reported	5 11.9%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	42 participants
	American Indian or Alaska Native	0 0.0%
	Asian	0 0.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%
	Black or African American	1 2.4%
	White	36 85.7%
	More than one race	2 4.8%
	Unknown or Not Reported	3 7.1%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	42 participants
		42
Lymphoma type; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	42 participants
	Follicular	28 66.7%
	Marginal zone	4 9.5%
	Small lymphocytic	10 23.8%

Outcome Measures

1. Primary Outcome

Title	Efficacy: Complete Response Rate (CRR)
Description	Evaluate clinical efficacy of ofatumumab in previously untreated indolent B-cell lymphomas, as measured by complete response rate (CRR). Complete response = all previously enlarged fluorodeoxyglucose (FDG)-avid or positron emission tomography (PET)-positive lymph nodes regressed to normal size (<=1.5 cm in greatest diameter)
Time Frame	1-month post-treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ofatumumab
Arm/Group Description:	single-arm, open-label, interventional ofatumumab: Weekly infusion for 8 weeks
Overall Number of Participants Analyzed	41
Measure Type: Number; Unit of Measure: percentage of patients
	9.5

2. Secondary Outcome

Title	Overall Response Rate (ORR)
Description	Evaluate clinical efficacy of ofatumumab in previously untreated indolent B-cell lymphomas, as measured by overall response rate (ORR). Overall response = Complete response (CR) + Partial response (PR) CR = all previously enlarged fluorodeoxyglucose (FDG)-avid or positron emission tomography (PET)-positive lymph nodes regressed to normal size (<=1.5cm in greatest diameter) PR = >=50% decrease in SPD of up to six largest dominant masses, no increase in size of other nodes; FDG avid or PET positive before therapy, one or more nodes PET positive at previously involved site, or variably FDG avid or PET negative with regression at CT
Time Frame	1-month post-treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ofatumumab
Arm/Group Description:	single-arm, open-label, interventional ofatumumab: Weekly infusion for 8 weeks
Overall Number of Participants Analyzed	41
Measure Type: Number; Unit of Measure: percentage of patients
	52

3. Secondary Outcome

Title	Progression-free Survival (PFS)
Description	Percentage of patients with progression-free survival during 12 months post-treatment progression-free survival: patients live with the disease, but it does not get worse
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ofatumumab
Arm/Group Description:	single-arm, open-label, interventional ofatumumab: Weekly infusion for 8 weeks
Overall Number of Participants Analyzed	41
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of patients
	86; (72 to 99)

4. Secondary Outcome

Title	Toxicity: Infusion Reactions, Grade 3-4 Infections, and Neutropenia
Description	Evaluate safety of ofatumumab monotherapy in this patient population Toxicities are graded 1 (mild), 2 (moderate), 3 (severe), and 4 (life-threatening)
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ofatumumab
Arm/Group Description:	single-arm, open-label, interventional ofatumumab: Weekly infusion for 8 weeks
Overall Number of Participants Analyzed	42
Measure Type: Count of Participants; Unit of Measure: Participants
Infusion reactions (grade 1-2)	22 52.4%
Infusion reactions (grade 3)	7 16.7%
Infections (grade 3-4)	1 2.4%
Neutropenia (grade 3-4)	0 0.0%

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Ofatumumab
Arm/Group Description	single-arm, open-label, interventional ofatumumab: Weekly infusion for 8 weeks
All-Cause Mortality
	Ofatumumab
	Affected / at Risk (%)
Total	--/--
Serious Adverse Events
	Ofatumumab
	Affected / at Risk (%)	# Events
Total	2/42 (4.76%)
Eye disorders
Photophobia [1]	1/42 (2.38%)	1
General disorders
Fever [2]	1/42 (2.38%)	1
Nervous system disorders
Vestibular Schwannoma [3]	1/42 (2.38%)	1
Headache [4]	1/42 (2.38%)	1
Respiratory, thoracic and mediastinal disorders
Pneumonia [5]	1/42 (2.38%)	1
[1] Grade 2, unexpected and unrelated; [2] Grade 2, expected and unrelated; [3] Grade 2, unrelated; [4] grade 3, expected and unrelated; [5] Grade 4, expected and unrelated
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Ofatumumab
	Affected / at Risk (%)	# Events
Total	38/42 (90.48%)
Blood and lymphatic system disorders
Anemia	4/42 (9.52%)	6
Gastrointestinal disorders
Nausea	9/42 (21.43%)	12
Diarrhea	6/42 (14.29%)	8
Abdominal pain	5/42 (11.90%)	7
Constipation	4/42 (9.52%)	4
Dyspepsia	3/42 (7.14%)	3
Vomiting	3/42 (7.14%)	3
General disorders
Fatigue	19/42 (45.24%)	21
Infusion related react	6/42 (14.29%)	6
Immune system disorders
Allergic reaction	28/42 (66.67%)	30
Infections and infestations
Bladder infection	3/42 (7.14%)	3
Investigations
Platelet count decrease	5/42 (11.90%)	5
Blood bilirubin increase	4/42 (9.52%)	4
Alanine aminotransferase	3/42 (7.14%)	5
Neutrophil count decrease	3/42 (7.14%)	3
Musculoskeletal and connective tissue disorders
Back pain	4/42 (9.52%)	5
Arthralgia	4/42 (9.52%)	4
Pain in extremity	4/42 (9.52%)	4
Nervous system disorders
Headache	7/42 (16.67%)	7
Dizziness	3/42 (7.14%)	3
Psychiatric disorders
Insomnia	5/42 (11.90%)	5
Anxiety	3/42 (7.14%)	3
Respiratory, thoracic and mediastinal disorders
Cough	6/42 (14.29%)	6
Dyspnea	5/42 (11.90%)	5
Skin and subcutaneous tissue disorders
Pruritus	5/42 (11.90%)	6
Rash maculo-papular	4/42 (9.52%)	5
Skin and subcutaneous	4/42 (9.52%)	4

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Jeremy Abramson, MD
• Organization: Massachusetts General Hospital Cancer Center
• Phone: 617-724-4000
• EMail: jabramson@mgh.harvard.edu

• Responsible Party: Jeremy Abramson, MD, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT01239394
• Other Study ID Numbers: 10-271
• First Submitted: November 10, 2010
• First Posted: November 11, 2010
• Results First Submitted: January 25, 2017
• Results First Posted: March 17, 2017
• Last Update Posted: October 18, 2017