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
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Sponsor:
GlaxoSmithKline
Collaborator:
Genmab
Information provided by (Responsible Party):
GlaxoSmithKline
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Tracking Information | ||||
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First Submitted Date ICMJE | December 4, 2008 | |||
First Posted Date ICMJE | December 5, 2008 | |||
Results First Submitted Date ICMJE | May 17, 2012 | |||
Results First Posted Date ICMJE | June 26, 2012 | |||
Last Update Posted Date | May 14, 2014 | |||
Study Start Date ICMJE | January 2009 | |||
Actual Primary Completion Date | September 2011 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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 [ Time Frame: Start of treatment (Week 0/Visit 2) until Week 52 ] 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.
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Original Primary Outcome Measures ICMJE |
Proportion of objective responders, according to the 1996 National Cancer Institute-Sponsored Working Group (NCI-WG) guidelines. [ Time Frame: 52-weeks from start of retreatment. ] | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Efficacy and Safety of Ofatumumab Retreatment and Maintenance Treatment in Patients With B-cell Chronic Lymphocytic Leukemia (CLL) | |||
Official Title ICMJE | A Single-arm, International, Multi-center Trial Investigating the Efficacy and Safety of Ofatumumab Retreatment and Maintenance in CLL Patients Who Progressed Following Response or Stable Disease After Ofatumumab Treatment in Hx-CD20-406 | |||
Brief Summary | The purpose of the trial is to investigate the efficacy and safety of ofatumumab retreatment and maintenance in patients with chronic lymphocytic leukemia who have previously responded or had disease stabilization after ofatumumab in an ongoing trial (Hx-CD20-406). | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Leukaemia, Lymphocytic, Chronic | |||
Intervention ICMJE | Drug: Ofatumumab
Eight once weekly infusions (1 x 300 mg + 7 x 2000 mg), then 2000 mg once monthly for two years
Other Name: HuMax-CD20
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Study Arms ICMJE | Experimental: Ofatumumab
Eight once weekly infusions (1 x 300 mg + 7 x 2000 mg), then 2000 mg once monthly for two years
Intervention: Drug: Ofatumumab
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Publications * | van Oers MH, Kuliczkowski K, Smolej L, Petrini M, Offner F, Grosicki S, Levin MD, Gupta I, Phillips J, Williams V, Manson S, Lisby S, Geisler C; PROLONG study investigators. Ofatumumab maintenance versus observation in relapsed chronic lymphocytic leukaemia (PROLONG): an open-label, multicentre, randomised phase 3 study. Lancet Oncol. 2015 Oct;16(13):1370-9. doi: 10.1016/S1470-2045(15)00143-6. Epub 2015 Sep 13. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
29 | |||
Original Estimated Enrollment ICMJE |
25 | |||
Actual Study Completion Date ICMJE | May 2013 | |||
Actual Primary Completion Date | September 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Sweden | |||
Removed Location Countries | Czech Republic, France, Germany, Italy, Poland, United Kingdom, United States | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00802737 | |||
Other Study ID Numbers ICMJE | 111827 GEN416 |
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Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | GlaxoSmithKline | |||
Original Responsible Party | Claus Strange, International Clinical Trial Manager, Genmab A/S, Clinical Development | |||
Current Study Sponsor ICMJE | GlaxoSmithKline | |||
Original Study Sponsor ICMJE | Genmab | |||
Collaborators ICMJE | Genmab | |||
Investigators ICMJE |
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PRS Account | GlaxoSmithKline | |||
Verification Date | April 2014 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |