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

Sponsor
Hoffmann-La Roche
Study ID
NCT00532129
Phase
PHASE2
Status
Completed

Conditions

  • Lymphocytic Leukemia, Chronic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    375mg/m\^2 IV on Day 1 of Cycle 1; 500mg/m\^2 on Day 1 of Cycles 2-6.
  • Chlorambucil — DRUG
    10 mg/m\^2/day PO on Days 1 to 7 of each cycle for a maximum of 12 cycles.

Study Details

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).

Key Dates

Start date
Nov 30, 2007
Status verified
Mar 2016
Primary completion
Apr 30, 2012
Completion
Apr 30, 2012

Study Design

Enrollment
100 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Percentage of Participants With Treatment-Emergent Adverse Events (AEs) [ Time Frame: First administration of study treatment up to 56 days after the beginning of the last treatment cycle (up to 365 days) ]

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