A Study of Rituximab (MabThera) in Participants With Chronic Lymphocytic Leukemia (CLL)

Roche

Status and phase: Completed; Phase 2

Conditions: Lymphocytic Leukemia, Chronic

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02533401

ML18429

Details and patient eligibility

About

This study will evaluate the efficacy and safety of rituximab in combination with chemotherapy (fludarabine and cyclophosphamide) in participants with B-cell CLL.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult participants greater than or equal to (≥) 18 years of age
• B-cell CLL
• No previous treatment for leukemia

Exclusion criteria

• History of other malignancies within 2 years before study entry, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, prostate cancer, or breast cancer
• Comorbid condition requiring long-term (greater than [>] 1 month) systemic corticosteroids during study treatment
• Known infection with hepatitis B or C virus or with human immunodeficiency virus (HIV)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 1 patient group

Rituximab + Fludarabine + Cyclophosphamide

Experimental group

Description:

Participants will receive rituximab (375 milligrams per meter-squared \[mg/m\^2\] intravenously \[IV\]) on Cycle 1 Day 1, followed by fludarabine (25 mg/m\^2 once daily IV) and cyclophosphamide (250 mg/m\^2 once daily IV) for Days 2 to 4 of Cycle 1. Then rituximab (500 mg/m\^2 IV) will be administered on Day 1 of Cycles 2 to 6, followed by IV fludarabine (25 mg/m\^2 once daily IV) and cyclophosphamide (250 mg/m\^2 once daily IV) on Days 1 to 3 of Cycles 2 to 6. Each cycle will be 28 days or 4 weeks in length, and the overall duration of treatment will be approximately 6 months.

Treatment:

Drug: Cyclophosphamide

Drug: Fludarabine

Drug: Rituximab