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

Mantle Cell Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00285389
• Other study ID #: MANTEAU 2001
• Status: Completed
• Phase: Phase 2
• First received: January 31, 2006
• Last updated: February 11, 2009
• Start date: February 2002
• Est. completion date: December 2008

Study information

• Verified date: February 2009
• Source: French Innovative Leukemia Organisation
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: December 2008
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Mantle-Cell
• Mantle Cell Lymphoma

Intervention

Drug:
• Adriblastin

• dexamethasone

• Chlorambucil

• rituximab

• cyclophosphamide

• alkeran

Procedure:
• Total body irradiation (8Gy/4fr)

Drug:
• vincristine
0,4 mg/day day 1 to day 4

Locations

Country	Name	City	State
France	Regional university hospital	Besancon
France	Regional university hospital	Rennes
France	REgional Hospital	Tours

Sponsors (2)

Lead Sponsor	Collaborator
Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS	Hoffmann-La Roche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	failure event free survival at 3 years		3 YEARS	Yes
Secondary	Response rate after 4 R-(VAD+C) cycles		4 months	Yes
Secondary	Incident of Molecular residual disease on blood, marrow and stem cell collection		3 years	Yes
Secondary	Safety of the R-( VAD+C) regimen		8 months	Yes
Secondary	Overall survival		3 years	Yes
Secondary	Efficacy of the stem cell collection after HD Cyclosphosphamide mobilization and rituximab purging		8 months	Yes