Brentuximab Vedotin and BeEAM High-dose Chemotherapy in Lymphomas

Phase 1/2 Suspended 20 enrolled Insel Gruppe AG, University Hospital Bern Mundipharma Medical Company · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The trial assess the maximum tolerated dose of a single-dose of Brentuximab Vedotin added to standard BeEAM chemotherapy (comprising Bendamustin, Etoposide, Cyclophosphamide and Melphalan) before autologous stem cell transplantation in CD30+ malignant lymphomas.

Timeline

Start: 2018-09-01
Primary completion: 2023-11-02
Completion: 2025-04-30

Outcome

Missed primary endpoint

Stopped (Enrollment): “low accrual”

paper After 22 months median follow-up, overall response-rate, complete remission-rate, disease-free survival and overall survival did not differ between groups. PMID 41117344 ↗

paper study was terminated early, after a futility analysis showed lack of benefit. PMID 41117344 ↗

Publications

Rausch C, Bacher U, Rabaglio M, Vorburger C, Klingenberg A, Banz Y, Daskalakis M, Pabst T. Randomized Phase II Study of Brentuximab-Vedotin With High-Dose Chemotherapy in CD30 Positive Lymphoma. Hematol Oncol. 2025 Nov;43(6):e70143. doi: 10.1002/hon.70143.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Brentuximab Vedotin	Monoclonal antibody	1.8 mg/kg	—
Background	Bendamustine	Small molecule	200 mg/m2	Intravenous
Background	Cytarabine	Small molecule	400 mg/m2	Intravenous
Background	Etoposide	Small molecule	200 mg/m2	Intravenous
Background	Melphalan	Small molecule	140 mg/m2	Intravenous