A Study of MabThera (Rituximab) Plus Chlorambucil in Participants With Chronic Lymphocytic Leukemia.

Roche

Status and phase: Completed; Phase 2

Conditions: Lymphocytic Leukemia, Chronic

Treatments: Drug: Chlorambucil; Drug: Rituximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00532129

MO20927

2007-000172-16 (EudraCT Number)

Details and patient eligibility

About

This single arm study will assess the safety and effect on response rate of a combination of rituximab and chlorambucil in previously untreated participants with B-cell chronic lymphocytic leukemia. Participants will receive 6 monthly cycles of combination treatment, followed by up to 6 cycles of chlorambucil alone. Rituximab will be administered on Day 1 of each cycle, at a dose of 375 milligrams per square meter (mg/m^2) intravenously (IV) in Cycle 1, and 500 mg/m^2 in subsequent cycles, and chlorambucil will be administered on Days 1-7 of each cycle at a dose of 10 mg/m^2/day per oral (PO).

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• previously untreated participants with cluster of differentiation 20 (CD20) positive B-cell chronic lymphocytic leukemia;
• participants with progressive Binet stage B, or C requiring therapy according to National Cancer Institute (NCI) criteria;
• Eastern Cooperative Oncology Group (ECOG) performance status <=2.

Exclusion criteria

• previous treatment for Chronic Lymphocytic Leukaemia (CLL);
• known concomitant hematological malignancy;
• transformation to aggressive B-cell malignancy;
• history of severe cardiac disease;
• known hypersensitivity or anaphylactic reactions to murine antibodies.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Rituximab plus Chlorambucil

Experimental group

Description:

Participants will receive combination therapy of rituximab plus chlorambucil for first 6 cycles and then chlorambucil alone for a maximum of 6 additional cycles.

Treatment:

Drug: Chlorambucil

Drug: Rituximab