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Rituximab Maintenance Versus Observation After First-line Immunochemotherapy by FCR in Older Patients With Chronic Lymphocytic Leukemia

NCT00645606 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 542

Last updated 2017-08-01

No results posted yet for this study

Summary

RATIONALE: Classical chemotherapy does not cure advanced chronic lymphocytic leukemia (CLL) despite new drugs. Rituximab is a monoclonal antibody directed against CD20 surface antigen on B lymphocytes and leads to apoptosis of CD20 positive B lymphocytes. The highest response rate yet published in the treatment of first-line CLL has been obtained by the association of fludarabine, cyclophosphamide and rituximab (FCR). Now, the question is whether this response can be improved, as some trials showed that eradication of minimal residual disease (MRD) in CLL is associated with a longer treatment-free and overall survival. Maintenance therapy using rituximab has been recently approved as a means of prolonging remission in patients with indolent non Hodgkin's lymphoma. Maintenance therapy with rituximab could be of interest in treatment of MRD in CLL and prolonging remission and survival times.

PURPOSE: The overall purpose of the study is to determine the value of immunotherapy maintenance with single agent rituximab in comparison with no further treatment (observation ) for previously untreated chronic lymphocytic leukaemia in elderly (\>65 years) patients who respond to induction immunochemotherapy with FCR.

Conditions

Interventions

BIOLOGICAL

Rituximab

rituximab :500 mg/m² every 8 weeks during 2 years

Sponsors & Collaborators

  • Roche Pharma AG

    collaborator INDUSTRY

  • French Innovative Leukemia Organisation

    collaborator OTHER

  • University Hospital, Tours

    lead OTHER

Principal Investigators

  • Caroline Dartigeas, MD · Hématologie et Thérapie Cellulaire Hôpital Bretonneau CHU Tours FRANCE

  • Eric VAN DEN NESTE, MD PhD · Département d'hématologie Cliniques Universitaires Saint Luc BRUSSELS BELGIUM

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2014-02-28
Completion
2017-07-31

Countries

  • France

Study Locations

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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 NCT00645606 on ClinicalTrials.gov