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

Sponsor

French Innovative Leukemia Organisation (Other)

Overall Status

Completed

CT.gov ID

NCT00285389

Collaborator

Hoffmann-La Roche (Industry)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Mantle Cell Lymphoma	Drug: Adriblastin Drug: dexamethasone Drug: Chlorambucil Drug: rituximab Drug: cyclophosphamide Drug: alkeran Procedure: Total body irradiation (8Gy/4fr) Drug: vincristine	Phase 2

Detailed Description

All patients at diagnosis with a stage II, III or IV an arbor disease are treated with 4 cycles of (R VAD +C) .

The responders more than RP > 50% received 2 other cycles before to be intensified with alkeran 140 mg/ m2 and a 8 grays TBI over 4 days before an autologous PBSCT.The stem cell collection is realised after a mobilisation with HD Cyclophosphamide (4 mg/m2) after the four R-(VAD + C) cycles and purged by a rituximab injection 10 days before the collection.

There is an clinical and molecular evaluation of the strategy

Study Design

Study Type:

Interventional

Actual Enrollment :

39 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Treatment in First Line of Mantle Cell Lymphoma for Patients Under 66 Years by the VAD-CHLORAMBUCIL -Rituximab Regimen Followed by Intensification and Autologous PBSC Transplantation After Marrow Purging With Rituximab

Study Start Date :

Feb 1, 2002

Actual Primary Completion Date :

Dec 1, 2005

Actual Study Completion Date :

Dec 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: VAD Clorambucil Rituximab	Drug: Adriblastin Drug: dexamethasone Drug: Chlorambucil Drug: rituximab Drug: cyclophosphamide Drug: alkeran Procedure: Total body irradiation (8Gy/4fr) Drug: vincristine 0,4 mg/day day 1 to day 4

Arm

Intervention/Treatment

Experimental: VAD Clorambucil Rituximab

Drug: Adriblastin

Drug: dexamethasone

Drug: Chlorambucil

Drug: rituximab

Drug: cyclophosphamide

Drug: alkeran

Procedure: Total body irradiation (8Gy/4fr)

Drug: vincristine

0,4 mg/day day 1 to day 4

Outcome Measures

Primary Outcome Measures

failure event free survival at 3 years [3 YEARS]

Secondary Outcome Measures

Response rate after 4 R-(VAD+C) cycles [4 months]
Incident of Molecular residual disease on blood, marrow and stem cell collection [3 years]
Safety of the R-( VAD+C) regimen [8 months]
Overall survival [3 years]
Efficacy of the stem cell collection after HD Cyclosphosphamide mobilization and rituximab purging [8 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Mantel cell lymphoma
CD 20+
At diagnosis or without anterior chemotherapy
Age >18 and < 66 years
Ann Arbor ii, III or IV
ECOG <3
contraindication for rituximab treatment
Informed consent signed
No cancer anteriory
Renal and hepatic function compatible with the treatment
Ventricular Fraction > 50 % with echographic method and > 40% with isotopic method