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

Sponsor
Hoffmann-La Roche
Study ID
NCT00545714
Phase
PHASE2
Status
Completed

Conditions

  • Leukemia, Lymphocytic, Chronic, B-Cell

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Cyclophosphamide — DRUG
    Cyclophosphamide 250 mg/m\^2 as IV infusion will be administered on Days 1-3 of first six 28-day cycles.
  • Fludarabine — DRUG
    Fludarabine 25 mg/m\^2 as IV infusion will be administered on Days 1-3 of first six 28-day cycles.
  • Rituximab — DRUG
    Rituximab 375 mg/m\^2 as IV infusion will be administered on Day 0 of Cycle 1; 500 mg/m\^2 as IV infusion will be administered on Day 1 of Cycle 2-6; and 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.

Study Details

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.

Key Dates

Start date
Nov 21, 2007
Status verified
Jul 2018
Primary completion
May 20, 2016
Completion
May 20, 2016

Study Design

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

Arms

  • Experimental: Rituximab + Fludarabine + Cyclophosphamide
    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.

Primary Outcome Measure

Percentage of Participants With CR Achieved After the Rituximab, Fludarabine, and Cyclophosphamide Regimen [ Time Frame: Month 9 ]

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