Treatment of Mantle Cell Lymphoma at Diagnosis for Patients Under 65 Years

NCT00285389 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2009-02-12

No results posted yet for this study

Summary

Phase II study to test in first line the VAD (Vincristine Adriablastine Dexamethasone) + C (Chlorambucil ) regimen associated to rituximab ( R-VAD + C ) in a cohort of young patients under 66 years with a mantle cell lymphoma and also the test the role of an in vivo marrow purge with rituximab before an autologous stem cell transplantation for the consolidation of the patients which fulfilled a response to 4 cycles of (R VAD + C) regimen.

Conditions

Interventions

DRUG

Adriblastin

DRUG

Chlorambucil

DRUG

rituximab

DRUG

alkeran

PROCEDURE

Total body irradiation (8Gy/4fr)

DRUG

vincristine

0,4 mg/day day 1 to day 4

Sponsors & Collaborators

  • Hoffmann-La Roche

    collaborator INDUSTRY
  • French Innovative Leukemia Organisation

    lead OTHER

Principal Investigators

  • Remy GRESSIN, MD · French Innovative Leukemia Organisation

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-02-28
Primary Completion
2005-12-31
Completion
2008-12-31

Countries

  • France

Study Locations

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Entities

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 NCT00285389 on ClinicalTrials.gov