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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00285389
Recruitment Status : Completed
First Posted : February 2, 2006
Last Update Posted : February 12, 2009
Hoffmann-La Roche
Information provided by:
French Innovative Leukemia Organisation

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

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Study Type : Interventional  (Clinical Trial)
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 : February 2002
Actual Primary Completion Date : December 2005
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

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

Primary Outcome Measures :
  1. failure event free survival at 3 years [ Time Frame: 3 YEARS ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00285389

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Regional university hospital
Besancon, France, 25000
Regional university hospital
Rennes, France, 35033
REgional Hospital
Tours, France, 37000
Sponsors and Collaborators
French Innovative Leukemia Organisation
Hoffmann-La Roche
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Principal Investigator: Remy GRESSIN, MD French Innovative Leukemia Organisation
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Dr Remy GRESSIN Principal Investigator, GOELAMS Identifier: NCT00285389    
Other Study ID Numbers: MANTEAU 2001
First Posted: February 2, 2006    Key Record Dates
Last Update Posted: February 12, 2009
Last Verified: February 2009
Keywords provided by French Innovative Leukemia Organisation:
Mantle cell lymphoma
Autologous PBSCT
Molecular evaluation
Additional relevant MeSH terms:
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Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents