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

This study has been completed.
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
ClinicalTrials.gov Identifier:
NCT00285389
First received: January 31, 2006
Last updated: February 11, 2009
Last verified: February 2009
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS:

Primary Outcome Measures:
  • failure event free survival at 3 years [ Time Frame: 3 YEARS ] [ Designated as safety issue: Yes ]

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

Enrollment: 39
Study Start Date: February 2002
Study Completion Date: December 2008
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00285389

Locations
France
Regional university hospital
Besancon, France, 25000
Regional university hospital
Rennes, France, 35033
REgional Hospital
Tours, France, 37000
Sponsors and Collaborators
Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
Hoffmann-La Roche
Investigators
Principal Investigator: Remy GRESSIN, MD Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
  More Information

Additional Information:
No publications provided by Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Remy GRESSIN Principal Investigator, GOELAMS
ClinicalTrials.gov Identifier: NCT00285389     History of Changes
Other Study ID Numbers: MANTEAU 2001
Study First Received: January 31, 2006
Last Updated: February 11, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS:
Mantle cell lymphoma
Chemotherapy
Autologous PBSCT
Molecular evaluation

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Mantle-Cell
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Chlorambucil
Cyclophosphamide
Dexamethasone
Rituximab
Alkylating Agents
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Hormonal
Antirheumatic Agents
Autonomic Agents
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists

ClinicalTrials.gov processed this record on October 23, 2014