A Study to Assess the Efficacy of Rituximab (MabThera) in First Line Treatment of Chronic Lymphocytic Leukemia (CLL)

Roche

Status and phase: Completed; Phase 2

Conditions: Leukemia, Lymphocytic, Chronic, B-Cell

Treatments: Drug: Cyclophosphamide; Drug: Rituximab; Drug: Fludarabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00545714

ML21135

2007-002733-36 (EudraCT Number)

Details and patient eligibility

About

This single arm study will assess the efficacy and safety of rituximab in combination with fludarabine and cyclophosphamide, followed by rituximab maintenance therapy, as first line treatment of participants with CLL.

Enrollment: 86 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• CLL according to World Health Organization diagnostic criteria
• Active disease
• No previous treatment
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

Exclusion criteria

• Transformation to aggressive B-cell malignancy (prolymphocytic leukemia, large-cell lymphoma, Hodgkin's lymphoma)
• Other malignancies except for localized skin cancer
• Continuous systemic corticosteroid treatment
• Known infection with hepatitis B or C

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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86 participants in 1 patient group

Rituximab + Fludarabine + Cyclophosphamide

Experimental group

Description:

Participants will receive 6 cycles (cycle length = 28 days) of treatment with rituximab (375 milligrams per square meter \[mg/m\^2\] as intravenous \[IV\] infusion on Day 0 of Cycle 1 and 500 mg/m\^2 as IV infusion on Day 1 of Cycles 2-6); fludarabine (25 mg/m\^2 on Days 1-3) and cyclophosphamide (250 mg/m\^2 on Days 1-3). Participants with a partial or complete response and appropriate neutrophil conditions will receive maintenance treatment with rituximab (375 mg/m\^2 as IV infusion every 2 months) from 3 months after Day 1 Cycle 6 up to a total of 18 doses or up to 3 years after Cycle 6.

Treatment:

Drug: Rituximab

Drug: Fludarabine

Drug: Cyclophosphamide