Efficacy and Safety of R-HAD Alone or in Combination With Bortezomib in Patients With Relapsed or Refractory MCL

Phase 3 Unknown 128 enrolled Prof. Dr. M. Dreyling (co-chairman) ClinAssess · collab GELARC Service de Pharmacovigilance, Pierre Benite · collab Klinikum der Universitaet Muenchen, Grosshadern · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the efficacy and safety of rituximab, high-dose ara-c and dexamethasone (r-had) alone or in combination with bortezomib in patients with relapsed or refractory mantle cell lymphoma.

Timeline

Start: 2009-05-09
Primary completion: 2018-12
Completion: 2018-12

Publications

Fischer L, Jiang L, Durig J, Schmidt C, Stilgenbauer S, Bouabdallah K, Solal-Celigny P, Scholz CW, Feugier P, de Wit M, Trappe RU, Hallek M, Graeven U, Hanel M, Hoffmann M, Delwail V, Macro M, Greiner J, Giagounidis AAN, Dargel B, Durot E, Foussard C, Silkenstedt E, Weigert O, Pott C, Klapper W, Hiddemann W, Unterhalt M, Hoster E, Ribrag V, Dreyling M. The addition of bortezomib to rituximab, high-dose cytarabine and dexamethasone in relapsed or refractory mantle cell lymphoma-a randomized, open-label phase III trial of the European mantle cell lymphoma network. Leukemia. 2024 Jun;38(6):1307-1314. doi: 10.1038/s41375-024-02254-2. Epub 2024 Apr 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ara-C: Cytarabine	Unknown	1000 mg/m2	Intravenous
Subject	Ara-C: Cytarabine	Unknown	2000 mg/m2	Intravenous
Subject	Bortezomib	Small molecule	1.5 mg/m2	Intravenous
Subject	Dexamethasone	Small molecule	40 mg	Oral
Subject	Rituximab	Monoclonal antibody	375 mg/m2	Intravenous

Efficacy and Safety of R-HAD Alone or in Combination With Bortezomib in Patients With Relapsed or Refractory MCL

Summary

Timeline

Publications

Drugs

Indications