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

Sponsor
French Innovative Leukemia Organisation
Study ID
NCT00285389
Phase
PHASE2
Status
Completed

Conditions

  • Mantle Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Adriblastin — DRUG
  • dexamethasone — DRUG
  • Chlorambucil — DRUG
  • rituximab — DRUG
  • cyclophosphamide — DRUG
  • alkeran — DRUG
  • Total body irradiation (8Gy/4fr) — PROCEDURE
  • vincristine — DRUG
    0,4 mg/day day 1 to day 4

Study Details

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.

Key Dates

Start date
Feb 28, 2002
Status verified
Feb 2009
Primary completion
Dec 31, 2005
Completion
Dec 31, 2008

Study Design

Enrollment
39 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: VAD Clorambucil Rituximab

Primary Outcome Measure

failure event free survival at 3 years [ Time Frame: 3 YEARS ]

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