A Study of MabThera (Rituximab) Plus Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia.

Roche

Status and phase: Completed; Phase 2

Conditions: Lymphocytic Leukemia, Chronic

Treatments: Drug: chlorambucil; Drug: rituximab [MabThera/Rituxan]

Study type: Interventional

Funder types: Industry

Identifiers

NCT00738374

ML21445

2008-001612-20

Details and patient eligibility

About

This single arm study will assess the efficacy and safety of MabThera + chlorambucil as induction therapy, followed in responders by maintenance therapy or observation in elderly patients with previously untreated chronic lymphocytic leukemia. During the induction phase patients will receive 2 x 4 weekly courses of chlorambucil followed by 8 x 4 weekly courses of chlorambucil + MabThera. Subsequently, responders will be randomized to receive 12 doses of MabThera given every 8 weeks, or no further treatment. The anticipated time on study treatment is 2+ years, and the target sample size is <100 individuals.

Enrollment: 97 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients, >=60 years of age;
• CD20+ chronic lymphocytic leukemia (CLL);
• no previous treatment for CLL;
• ECOG performance status 0-1.

Exclusion criteria

• co-morbid conditions requiring long term use of systemic corticosteroids during study treatment;
• history of severe cardiac disease;
• transformation to aggressive B-cell malignancy.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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97 participants in 1 patient group

1

Experimental group

Treatment:

Drug: rituximab [MabThera/Rituxan]

Drug: chlorambucil