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

Primary Purpose

Mantle Cell Lymphoma

Status

Completed

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

Adriblastin

dexamethasone

Chlorambucil

rituximab

cyclophosphamide

alkeran

Total body irradiation (8Gy/4fr)

vincristine

About this trial

This is an interventional treatment trial for Mantle Cell Lymphoma focused on measuring Mantle cell lymphoma, Chemotherapy, Autologous PBSCT, Molecular evaluation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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 Exclusion Criteria: Other type of lymphoma age<18 ou > 66 years Informed consent not signed anterior cancer Contraindication to rituximab Cardiac insufficiency

Sites / Locations

Regional university hospital
Regional university hospital
REgional Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

VAD Clorambucil Rituximab

Arm Description

Outcomes

Primary Outcome Measures

failure event free survival at 3 years

Secondary Outcome Measures

Response rate after 4 R-(VAD+C) cycles

Incident of Molecular residual disease on blood, marrow and stem cell collection

Safety of the R-( VAD+C) regimen

Overall survival

Efficacy of the stem cell collection after HD Cyclosphosphamide mobilization and rituximab purging

Full Information

NCT ID

NCT00285389

First Posted

January 31, 2006

Last Updated

February 11, 2009

Sponsor

French Innovative Leukemia Organisation

Collaborators

Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT00285389

Brief Title

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

2. Study Status

Record Verification Date

February 2009

Overall Recruitment Status

Completed

Study Start Date

February 2002 (undefined)

Primary Completion Date

December 2005 (Actual)

Study Completion Date

December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

French Innovative Leukemia Organisation

Collaborators

Hoffmann-La Roche

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mantle Cell Lymphoma

Keywords

Mantle cell lymphoma, Chemotherapy, Autologous PBSCT, Molecular evaluation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

39 (Actual)

8. Arms, Groups, and Interventions

Arm Title

VAD Clorambucil Rituximab

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Adriblastin

Intervention Type

Drug

Intervention Name(s)

dexamethasone

Intervention Type

Drug

Intervention Name(s)

Chlorambucil

Intervention Type

Drug

Intervention Name(s)

rituximab

Intervention Type

Drug

Intervention Name(s)

cyclophosphamide

Intervention Type

Drug

Intervention Name(s)

alkeran

Intervention Type

Procedure

Intervention Name(s)

Total body irradiation (8Gy/4fr)

Intervention Type

Drug

Intervention Name(s)

vincristine

Intervention Description

0,4 mg/day day 1 to day 4

Primary Outcome Measure Information:

Title

failure event free survival at 3 years

Time Frame

3 YEARS

Secondary Outcome Measure Information:

Title

Response rate after 4 R-(VAD+C) cycles

Time Frame

4 months

Title

Incident of Molecular residual disease on blood, marrow and stem cell collection

Time Frame

3 years

Title

Safety of the R-( VAD+C) regimen

Time Frame

8 months

Title

Overall survival

Time Frame

3 years

Title

Efficacy of the stem cell collection after HD Cyclosphosphamide mobilization and rituximab purging

Time Frame

8 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Remy GRESSIN, MD

Organizational Affiliation

French Innovative Leukemia Organisation

Official's Role

Principal Investigator

Facility Information:

Facility Name

Regional university hospital

City

Besancon

ZIP/Postal Code

25000

Country

France

Facility Name

Regional university hospital

City

Rennes

ZIP/Postal Code

35033

Country

France

Facility Name

REgional Hospital

City

Tours

ZIP/Postal Code

37000

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

20220059

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.

Results Reference

derived

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

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