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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 2
18 Years
65 Years
Not Enrolling
Both
Mantle Cell Lymphoma

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Trial Information

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


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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

failure event free survival at 3 years

Outcome Time Frame:

3 YEARS

Safety Issue:

Yes

Principal Investigator

Remy GRESSIN, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

MANTEAU 2001

NCT ID:

NCT00285389

Start Date:

February 2002

Completion Date:

December 2008

Related Keywords:

  • Mantle Cell Lymphoma
  • Mantle cell lymphoma
  • Chemotherapy
  • Autologous PBSCT
  • Molecular evaluation
  • Lymphoma
  • Lymphoma, Mantle-Cell

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