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

NCT ID: NCT02533401

Last Updated: 2016-05-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2014-12-31

Brief Summary

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

Conditions

Lymphocytic Leukemia, Chronic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rituximab + Fludarabine + Cyclophosphamide

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.

Group Type: EXPERIMENTAL

Cyclophosphamide

Intervention Type: DRUG

Cyclophosphamide will be administered IV at 250 mg/m\^2/day on Day 2-4 of Cycle 1 and then on Day 1-3 of Cycles 2 to 6. Each cycle will be 28 days or 4 weeks in length.

Fludarabine

Intervention Type: DRUG

Fludarabine will be administered IV at 25 mg/m\^2/day on Day 2-4 of Cycle 1 and then on Day 1-3 of Cycles 2 to 6. Each cycle will be 28 days or 4 weeks in length.

Rituximab

Intervention Type: DRUG

Rituximab will be administered IV at 375 mg/m\^2 on Day 1 of Cycle 1 and then at 500 mg/m\^2 on Day 1 of Cycles 2 to 6. Each cycle will be 28 days or 4 weeks in length.

Interventions

Cyclophosphamide

Cyclophosphamide will be administered IV at 250 mg/m\^2/day on Day 2-4 of Cycle 1 and then on Day 1-3 of Cycles 2 to 6. Each cycle will be 28 days or 4 weeks in length.

Intervention Type: DRUG

Fludarabine

Fludarabine will be administered IV at 25 mg/m\^2/day on Day 2-4 of Cycle 1 and then on Day 1-3 of Cycles 2 to 6. Each cycle will be 28 days or 4 weeks in length.

Intervention Type: DRUG

Rituximab

Rituximab will be administered IV at 375 mg/m\^2 on Day 1 of Cycle 1 and then at 500 mg/m\^2 on Day 1 of Cycles 2 to 6. Each cycle will be 28 days or 4 weeks in length.

Intervention Type: DRUG

Other Intervention Names

MabThera/Rituxan

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_CHAIR

Hoffmann-La Roche

Locations

Buenos Aires, , Argentina

Buenos Aires, , Argentina

Buenos Aires, , Argentina

Buenos Aires, , Argentina

Córdoba, , Argentina

La Plata, , Argentina

Pilar, , Argentina

Rosario, , Argentina

Caracas, , Venezuela

Countries

Argentina; Venezuela

Other Identifiers

ML18429

Identifier Type: -

Identifier Source: org_study_id