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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Leukaemia, Lymphocytic, Chronic

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Trial Information

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


Inclusion Criteria:



1. Tumor cell phenotype consistent with B-CLL

2. Patients with active B-CLL and with an indication for treatment

3. Failing at least one fludarabine-containing treatment regimen

4. Failing at least one alemtuzumab-containing treatment regimen

5. ECOG Performance Status of 0, 1, or 2

6. Life expectancy of at least 4 months

Exclusion Criteria:

1. Previous treatment with alemtuzumab within 6 weeks prior to Visit 2

2. Previous autologous stem cell transplantation within 6 months prior to Visit 2

3. Allogeneic stem cell transplantation

4. Radioimmunotherapy

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Description:

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.

Outcome Time Frame:

Start of treatment (Week 0 of Visit 2) until Week 24

Safety Issue:

No

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: Food and Drug Administration

Study ID:

111773

NCT ID:

NCT00349349

Start Date:

June 2006

Completion Date:

June 2012

Related Keywords:

  • Leukaemia, Lymphocytic, Chronic
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid

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