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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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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

Conditions
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Mantle Cell Lymphoma

Intervention / Treatment
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* Drug: Adriblastin
* Drug: dexamethasone
* Drug: Chlorambucil
* Drug: rituximab
* Drug: cyclophosphamide
* Drug: alkeran
* Procedure: Total body irradiation (8Gy/4fr)
* Drug: vincristine


Participation Criteria
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Eligibility Criteria
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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 Exclusion Criteria: Other type of lymphoma age<18 ou > 66 years Informed consent not signed anterior cancer Contraindication to rituximab Cardiac insufficiency

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| failure event free survival at 3 years |  | 3 YEARS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mantle cell lymphoma, Chemotherapy, Autologous PBSCT, Molecular evaluation