HuMax-CD20 in B-Cell Chronic Lymphocytic Leukemia (B-CLL) Patients Failing Fludarabine and Alemtuzumab
A Single-arm, International, Multi-center Trial of HuMax-CD20, a Fully Human Monoclonal Anti-CD20 Antibody, in Patients With B-cell Chronic Lymphocytic Leukemia Who Have Failed Fludarabine and Alemtuzumab
2 other identifiers
interventional
223
0 countries
N/A
Brief Summary
The purpose of this study is to determine whether HuMax-CD20 (ofatumumab) is effective in the treatment of patients failing both fludarabine and alemtuzumab.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2006
Longer than P75 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 6, 2006
CompletedFirst Posted
Study publicly available on registry
July 7, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedResults Posted
Study results publicly available
November 29, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedJune 4, 2014
June 1, 2013
1.9 years
July 6, 2006
October 20, 2011
May 29, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants (Par.) Classified as Responders and Non-responders for Objective Response as Assessed by an Independent Endpoint Review Committee (IRC) in Accordance With the National Cancer Institute Working Group (NCIWG) 1996 Guidelines
Par. with complete remission (CR), nodular partial remission (nPR), and partial remission (PR) were classified as responders, while those with stable disease (SD) and progressive disease (PD) were classified as non-responders. Per the NCIWG guideline (1996): CR; no lymphadenopathy/hepatomegaly/splenomegaly/constitutional symptoms, normal hematology, bone marrow sample as normocellular for age, \<30% lymphocytes (LC), no lymphoid nodule; PR: a \>=50% decrease in LC/lymphadenopathy; nPR: persistent nodules in bone marrow; PD: new lesion or increase by \>=50% from baseline; SD: no CR, PR, or PD.
Start of treatment (Week 0 of Visit 2) until Week 24
Secondary Outcomes (22)
Duration of Response
Start of treatment (Week 0 of Visit 2) until Week 24
Progression-Free Survival (PFS)
Start of treatment (Week 0 of Visit 2) until Week 24
Time to Next Chronic Lymphocytic Leukemia (CLL) Treatment
Time from randomization (Week 0 of Visit 2) until the time of first administration of a CLL treatment other than ofatumumab (assessed for a median of 8.7 weeks currently [or up to 13.3 months])
Overall Survival
Start of randomization (Week 0 of Visit 2) until death (up to a median of 17.1 weeks)
Percent Change From Baseline to Week 7 in Peripheral CD5+CD19+ Cell Counts
Baseline (Visit 2) until Week 7 (Visit 9)
- +17 more secondary outcomes
Study Arms (1)
ofatumumab
EXPERIMENTALAnti-CD20 antibody therapy
Interventions
Eligibility Criteria
You may qualify if:
- Tumor cell phenotype consistent with B-CLL
- Patients with active B-CLL and with an indication for treatment
- Failing at least one fludarabine-containing treatment regimen
- Failing at least one alemtuzumab-containing treatment regimen
- ECOG Performance Status of 0, 1, or 2
- Life expectancy of at least 4 months
You may not qualify if:
- Previous treatment with alemtuzumab within 6 weeks prior to Visit 2
- Previous autologous stem cell transplantation within 6 months prior to Visit 2
- Allogeneic stem cell transplantation
- Radioimmunotherapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Related Publications (3)
Wierda WG, Padmanabhan S, Chan GW, Gupta IV, Lisby S, Osterborg A; Hx-CD20-406 Study Investigators. Ofatumumab is active in patients with fludarabine-refractory CLL irrespective of prior rituximab: results from the phase 2 international study. Blood. 2011 Nov 10;118(19):5126-9. doi: 10.1182/blood-2011-04-348656. Epub 2011 Aug 19.
PMID: 21856867BACKGROUNDWierda WG, Kipps TJ, Mayer J, Stilgenbauer S, Williams CD, Hellmann A, Robak T, Furman RR, Hillmen P, Trneny M, Dyer MJ, Padmanabhan S, Piotrowska M, Kozak T, Chan G, Davis R, Losic N, Wilms J, Russell CA, Osterborg A; Hx-CD20-406 Study Investigators. Ofatumumab as single-agent CD20 immunotherapy in fludarabine-refractory chronic lymphocytic leukemia. J Clin Oncol. 2010 Apr 1;28(10):1749-55. doi: 10.1200/JCO.2009.25.3187. Epub 2010 Mar 1.
PMID: 20194866RESULTStruemper H, Sale M, Patel BR, Ostergaard M, Osterborg A, Wierda WG, Hagenbeek A, Coiffier B, Jewell RC. Population pharmacokinetics of ofatumumab in patients with chronic lymphocytic leukemia, follicular lymphoma, and rheumatoid arthritis. J Clin Pharmacol. 2014 Jul;54(7):818-27. doi: 10.1002/jcph.268. Epub 2014 Jan 28.
PMID: 24443277DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 6, 2006
First Posted
July 7, 2006
Study Start
June 1, 2006
Primary Completion
May 1, 2008
Study Completion
June 1, 2012
Last Updated
June 4, 2014
Results First Posted
November 29, 2011
Record last verified: 2013-06