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

French Innovative Leukemia Organisation

Status and phase: Completed; Phase 2

Conditions: Mantle Cell Lymphoma

Treatments: Drug: alkeran; Drug: rituximab; Procedure: Total body irradiation (8Gy/4fr); Drug: Adriblastin; Drug: dexamethasone; Drug: vincristine; Drug: Chlorambucil; Drug: cyclophosphamide

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00285389

MANTEAU 2001

Details and patient eligibility

About

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.

Full 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

Enrollment: 39 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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39 participants in 1 patient group

VAD Clorambucil Rituximab

Experimental group

Treatment:

Drug: cyclophosphamide

Drug: dexamethasone

Drug: rituximab

Drug: Adriblastin

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

Drug: vincristine

Drug: Chlorambucil

Drug: alkeran