FCR or BR in Patients With Previously Untreated B-Cell Chronic Lymphocytic Leukemia

Sponsor
German CLL Study Group
Study ID
NCT00769522
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Rituximab — BIOLOGICAL
    cycle 1: 375 mg/m² i.v., day 0, q28d cycle 2-6: 500 mg/m² i.v., day 1, q28d
  • Bendamustine — DRUG
    cycle 1-6: 90mg/m² i.v., day 1-2, q28d
  • Cyclophosphamide — DRUG
    cycle 1-6: 250 mg/m² i.v., days 1-3, q28d
  • Fludarabine — DRUG
    cycle 1-6: 25 mg/m² i.v., days 1-3, q28d

Study Details

RATIONALE: Drugs used in chemotherapy, such as fludarabine, cyclophosphamide, and bendamustine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. It is not yet known whether giving fludarabine and cyclophosphamide together with rituximab is more effective than giving bendamustine together with rituximab in treating chronic lymphocytic leukemia. PURPOSE: This randomized phase III trial is studying fludarabine, cyclophosphamide, and rituximab to see how well they work compared with bendamustine and rituximab in treating patients with previously untreated B-cell chronic lymphocytic leukemia.

Key Dates

Start date
Oct 2, 2008
Status verified
Dec 2024
Primary completion
Jul 31, 2011
Completion
Jan 31, 2018

Study Design

Enrollment
564 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: FCR
  • Experimental: BR

Primary Outcome Measure

Progression-free survival rate after 24 months [ Time Frame: 2008-2015 ]

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