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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00285389

Enrollment

Registered

2006-02-02

Start date

2002-02-28

Completion date

2008-12-31

Last updated

2009-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mantle Cell Lymphoma

Keywords

Mantle cell lymphoma, Chemotherapy, Autologous PBSCT, Molecular evaluation

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

Interventions

DRUGAdriblastin

DRUGdexamethasone

DRUGChlorambucil

DRUGrituximab

DRUGcyclophosphamide

DRUGalkeran

PROCEDURETotal body irradiation (8Gy/4fr)

DRUGvincristine

0,4 mg/day day 1 to day 4

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
failure event free survival at 3 years	3 YEARS

Secondary

Measure	Time frame
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
Efficacy of the stem cell collection after HD Cyclosphosphamide mobilization and rituximab purging	8 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026