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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:
French Innovative Leukemia Organisation
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
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

Resource links provided by NLM:


Further study details as provided by French Innovative Leukemia Organisation:

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

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

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   (Adult)
Sexes Eligible for Study:   All
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
French Innovative Leukemia Organisation
Hoffmann-La Roche
Investigators
Principal Investigator: Remy GRESSIN, MD French Innovative Leukemia Organisation
  More Information

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

Keywords provided by French Innovative Leukemia Organisation:
Mantle cell lymphoma
Chemotherapy
Autologous PBSCT
Molecular evaluation

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Dexamethasone
Cyclophosphamide
Rituximab
Vincristine
Chlorambucil
Doxorubicin
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Antineoplastic Agents, Alkylating

ClinicalTrials.gov processed this record on September 21, 2017