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

February 11, 2009 updated by: French Innovative Leukemia Organisation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

39

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besancon, France, 25000
        • Regional University Hospital
      • Rennes, France, 35033
        • Regional University Hospital
      • Tours, France, 37000
        • Regional Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
failure event free survival at 3 years
Time Frame: 3 YEARS
3 YEARS

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

French Innovative Leukemia Organisation

Collaborators

Hoffmann-La Roche

Investigators

  • Principal Investigator: Remy GRESSIN, MD, French Innovative Leukemia Organisation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2002

Primary Completion (Actual)

December 1, 2005

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

January 31, 2006

First Submitted That Met QC Criteria

January 31, 2006

First Posted (Estimate)

February 2, 2006

Study Record Updates

Last Update Posted (Estimate)

February 12, 2009

Last Update Submitted That Met QC Criteria

February 11, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MANTEAU 2001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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