HuMax-CD20 in B-Cell Chronic Lymphocytic Leukemia (B-CLL) Patients Failing Fludarabine and Alemtuzumab

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Leukaemia, Lymphocytic, Chronic

Treatments: Drug: ofatumumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00349349

111773

Hx-CD20-406 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to determine whether HuMax-CD20 (ofatumumab) is effective in the treatment of patients failing both fludarabine and alemtuzumab.

Enrollment: 223 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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223 participants in 1 patient group

ofatumumab

Experimental group

Description:

Anti-CD20 antibody therapy

Treatment:

Drug: ofatumumab