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OpenTrials
Completed

NCT Number: NCT00285389

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

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.

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Key information

Conditions

Mantle Cell Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Regional university hospital, Besançon, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adriblastin

Drug

Dexamethasone

Drug

Chlorambucil

Drug

Rituximab

Drug

Cyclophosphamide

Drug

alkeran

Drug

Total body irradiation (8Gy/4fr)

Procedure

Vincristine

Drug

0,4 mg/day day 1 to day 4

Primary outcomes

  1. failure event free survival at 3 years

    Time frame: 3 YEARS

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

French Innovative Leukemia Organisation

Other

Collaborators

  • Hoffmann-La Roche

Registry information

Official study 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

Important dates

Study start
2002
Primary completion
2005
Study completion
2008
First posted
Feb 2, 2006
Registry last updated
Feb 12, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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