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

Phase 2

Completed

• Conditions: Mantle Cell Lymphoma
• Interventions: Drug: Adriblastin; Drug: dexamethasone; Drug: Chlorambucil; Drug: rituximab; Drug: cyclophosphamide; Drug: alkeran; Procedure: Total body irradiation (8Gy/4fr); Drug: vincristine

• Registration Number: NCT00285389
• Lead Sponsor: French Innovative Leukemia Organisation

Brief 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.

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

Study Timeline

• Study Start: 2002-02
• Primary Completion: 2005-12
• Study First Submitted: 2006-01-31
• Study First Submitted QC: 2006-01-31
• Study First Posted: 2006-02-02
• Study Completion: 2008-12
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-11
• Last Update Posted: 2009-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

Read More

Exclusion Criteria

• Other type of lymphoma
• age<18 ou > 66 years
• Informed consent not signed
• anterior cancer
• Contraindication to rituximab
• Cardiac insufficiency

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
VAD Clorambucil Rituximab	Adriblastin	-
VAD Clorambucil Rituximab	cyclophosphamide	-
VAD Clorambucil Rituximab	alkeran	-
VAD Clorambucil Rituximab	Total body irradiation (8Gy/4fr)	-
VAD Clorambucil Rituximab	vincristine	-
VAD Clorambucil Rituximab	rituximab	-
VAD Clorambucil Rituximab	dexamethasone	-
VAD Clorambucil Rituximab	Chlorambucil	-

Primary Outcome Measures

Name	Time	Method
failure event free survival at 3 years	3 YEARS

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Regional university hospital; 🇫🇷 Rennes, France

REgional Hospital; 🇫🇷 Tours, France