Clinical trial NCT00285389: Treatment of Mantle Cell Lymphoma at Diagnosis for Patients Under 65 Years
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Mantle Cell Lymphoma
Keywords: Mantle cell lymphoma
Chemotherapy
Autologous PBSCT
Molecular evaluation
Lead sponsor: French Innovative Leukemia Organisation
Sponsor class: OTHER
Collaborators: name: Hoffmann-La Roche
First posted: 2006-02-02
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: failure event free survival at 3 years
timeFrame: 3 YEARS
Secondary outcomes:
measure: Response rate after 4 R-(VAD+C) cycles
timeFrame: 4 months
measure: Incident of Molecular residual disease on blood, marrow and stem cell collection
timeFrame: 3 years
measure: Safety of the R-( VAD+C) regimen
timeFrame: 8 months
measure: Overall survival
timeFrame: 3 years
measure: Efficacy of the stem cell collection after HD Cyclosphosphamide mobilization and rituximab purging
timeFrame: 8 months
Other outcomes:
Locations:
city: Besancon
country: France
facility: Regional university hospital
city: Rennes
country: France
facility: Regional university hospital
city: Tours
country: France
facility: REgional Hospital
Study officials:
affiliation: French Innovative Leukemia Organisation
name: Remy GRESSIN, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gressin R, Caulet-Maugendre S, Deconinck E, Tournilhac O, Gyan E, Moles MP, El Yamani A, Cornillon J, Rossi JF, Le Gouill S, Lepeu G, Damaj G, Celigny PS, Maisonneuve H, Corront B, Vilque JP, Casassus P, Lamy T, Colonna M, Colombat P; French GOELAMS Group. Evaluation of the (R)VAD+C regimen for the treatment of newly diagnosed mantle cell lymphoma. Combined results of two prospective phase II trials from the French GOELAMS group. Haematologica. 2010 Aug;95(8):1350-7. doi: 10.3324/haematol.2009.011759. Epub 2010 Mar 10.