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

GlaxoSmithKline0 sites223 target enrollmentJune 2006

ConditionsLeukaemia, Lymphocytic, Chronic

Interventionsofatumumab

Drugsofatumumab

Overview

Phase: Phase 2
Intervention: ofatumumab
Conditions: Leukaemia, Lymphocytic, Chronic
Sponsor: GlaxoSmithKline
Enrollment: 223
Primary Endpoint: 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
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2006

End Date

June 2012

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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

Arms & Interventions

ofatumumab

Anti-CD20 antibody therapy

Intervention: ofatumumab

Outcomes

Primary Outcomes

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

Time Frame: Start of treatment (Week 0 of Visit 2) until Week 24

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.

Secondary Outcomes

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))
Percent Change From Baseline to Week 7 in Peripheral CD5+CD20+ Cell Counts(Baseline (Visit 2) until Week 7 (Visit 9))
Median Percent Change of Tumor Size (Sum of Products Dimensions [SPD]) From Baseline (Visit 2) to Week 24 (Visit 14)(Baseline (Visit 2) until Week 24 (Visit 14))
Number of Participants With Complete Resolution of Constitutional Symptoms at Week 24(Baseline (Visit 2) and Week 24)
Number of Participants With Complete Resolution of Lymphadenopathy(Baseline (Visit 2) to end of study (up to Week 24))
Number of Participants With Improvement on the Eastern Cooperative Oncology Group (ECOG) Performance Status Scale at Week 24(Baseline (Visit 2) and Week 24)
Number of Participants Who Were Positive, Negative, or Had Missing Data for the Indicated Fluorescence in Situ Hybridization (FISH) Prognostic Factors at Screening(Screening (Visit 1, <=14 days prior to Visit 2))
Number of Participants With Improvement in Hemoglobin(Baseline (Visit 2) to Week 28)
Number of Participants With Improvement in Thrombocytopenia (Thromb.)(Baseline (Visit 2) to Week 28)
Number of Participants With Complete Resolution of Hepatomegaly(Baseline (Visit 2) until Week 24)
Number of Participants With Improvement in Neutropenia(Baseline (Visit 2) to Week 28)
Number of Participants With Complete Resolution of Splenomegaly(Baseline (Visit 2) until Week 24)
Number of Participants Who Experienced Any Adverse Event(From first infusion (Visit 2/Week 0) to Visit 21 (Month 24 of follow-up [up to Month 48]) or time of withdrawal (treatment and follow-up))
Cmax and Ctrough at Dose 1 (Visit 2, Week 0), Dose 8 (Visit 9, Week 7), and Dose 12 (Visit 14, Week 24)(Visit 2 (Week 0), Visit 9 (Week 7), and Visit 14 (Week 24))
AUC (0-inf) and AUC(0-tau) at Dose 8 (Visit 9, Week 7) and Dose 12 (Visit 14, Week 24)(Visit 9 (Week 7) and Visit 14 (Week 24))
Half-life (t1/2) at Dose 8 (Visit 9, Week 7) and at Dose 12 (Visit 14, Week 24)(Visit 9 (Week 7) and Visit14 (Week 24))
Clearance (CL) After Dose 8 (Visit 9, Week 7) and Dose 12 (Visit 14, Week 24)(Visit 9 (Week 7) and Visit 14 (Week 24))
Volume of Distribution at Steady State (Vss) at Dose 8 (Visit 9, Week 7) and at Dose 12 (Visit 14, Week 24)(Visit 9 (Week 7) and Visit 14 (Week 24))