MedTrace Logo

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

NCT00769522 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 564

Last updated 2024-12-31

No results posted yet for this study

Summary

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.

Conditions

Interventions

BIOLOGICAL

Rituximab

cycle 1: 375 mg/m² i.v., day 0, q28d cycle 2-6: 500 mg/m² i.v., day 1, q28d

DRUG

Bendamustine

cycle 1-6: 90mg/m² i.v., day 1-2, q28d

DRUG

Cyclophosphamide

cycle 1-6: 250 mg/m² i.v., days 1-3, q28d

DRUG

Fludarabine

cycle 1-6: 25 mg/m² i.v., days 1-3, q28d

Sponsors & Collaborators

  • Roche Pharma AG

    collaborator INDUSTRY

  • Mundipharma Pte Ltd.

    collaborator INDUSTRY

  • German CLL Study Group

    lead OTHER

Principal Investigators

  • Barbara Eichhorst, MD · Medizinische Universitaetsklinik I at the University of Cologne

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-02
Primary Completion
2011-07-31
Completion
2018-01-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00769522 on ClinicalTrials.gov