Intergroup Trial for Children or Adolescents With Primary Mediastinal Large B-Cell Lymphoma: DA-EPOCH-Rituximab Evaluation

Phase 2 Completed 47 enrolled Gustave Roussy, Cancer Campus, Grand Paris Children's Oncology Group · collab

NaSingle-groupOpen-labelTreatment

Summary

Phase II trial to determine the efficacy of Dose Adjusted-EPOCH-Rituximab regimen in children and adolescent with primary mediastinal large B cell lymphoma in terms of event free survival.

Timeline

Start: 2012-04-01
Primary completion: 2017-04
Completion: 2022-11-16

Outcome

Missed primary endpoint

paper DA-EPOCH-R did not improve the EFS compared with a historical control in this first prospective multisite international study of children and adolescents with PMLBL. PMID 34570655 ↗

paper which did not differ from the rate observed historically (P = .59). PMID 34570655 ↗

Publications

Burke GAA, Minard-Colin V, Auperin A, Alexander S, Pillon M, Delgado R, Zsiros J, Uyttebroeck A, Dartigues P, Miles RR, Kazanowska B, Chiang AK, Haouy S, Bollard CM, Csoka M, Wheatley K, Barkauskas DA, Adamson PC, Vassal G, Patte C, Gross TG. Dose-Adjusted Etoposide, Doxorubicin, and Cyclophosphamide With Vincristine and Prednisone Plus Rituximab Therapy in Children and Adolescents With Primary Mediastinal B-Cell Lymphoma: A Multicenter Phase II Trial. J Clin Oncol. 2021 Nov 20;39(33):3716-3724. doi: 10.1200/JCO.21.00920. Epub 2021 Sep 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cyclophosphamide	Other / unclassified	—	—
Subject	Doxorubicin	Other / unclassified	—	—
Subject	Etoposide	Small molecule	—	—
Subject	Rituximab	Monoclonal antibody	375 mg/m2	Intravenous
Subject	Vincristine	Small molecule	—	—