Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mantle Cell Lymphoma | Mantle Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adriblastin | Drug | — | UNRESOLVED |
| alkeran | Drug | Melphalan | ALIAS |
| Chlorambucil | Drug | Chlorambucil | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| dexamethasone | Drug | Dexamethasone | ALIAS |
| rituximab | Drug | Rituximab | ALIAS |
| Total body irradiation (8Gy/4fr) | Procedure | — | UNRESOLVED |
| vincristine | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- VAD Clorambucil Rituximab
- interventionNames
- Drug: Adriblastin
- Drug: dexamethasone
- Drug: Chlorambucil
- Drug: rituximab
- Drug: cyclophosphamide
- Drug: alkeran
- Procedure: Total body irradiation (8Gy/4fr)
- Drug: vincristine
Primary outcomes (1)
- measure
- failure event free survival at 3 years
- timeFrame
- 3 YEARS
Secondary outcomes (5)
- measure
- Response rate after 4 R-(VAD+C) cycles
- timeFrame
- 4 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDGressin R, Caulet-Maugendre S, Deconinck E, Tournilhac O, Gyan E, Moles MP, El Yamani A, Cornillon J, Rossi JF, Le Gouill S, Lepeu G, Damaj G, Celigny PS, Maisonneuve H, Corront B, Vilque JP, Casassus P, Lamy T, Colonna M, Colombat P; French GOELAMS Group. Evaluation of the (R)VAD+C regimen for the treatment of newly diagnosed mantle cell lymphoma. Combined results of two prospective phase II trials from the French GOELAMS group. Haematologica. 2010 Aug;95(8):1350-7. doi: 10.3324/haematol.2009.011759. Epub 2010 Mar 10. PMID 20220059