Brentuximab Vedotin and Bendamustine for the Treatment of Hodgkin Lymphoma and Anaplastic Large Cell Lymphoma (ALCL)

Phase 1/2 Completed 65 enrolled Columbia University

NaSingle-groupOpen-labelTreatment

Summary

This is a phase 1/2 multicenter study to assess the safety and effectiveness of brentuximab vedotin and bendamustine, when given together, in patients with Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma (ALCL) that has either returned or did not respond to initial treatment(s). Patients will be accrued at Columbia University Medical Center (CUMC) and at two subsites in Canada.

Timeline

Start: 2012-07
Primary completion: 2018-06
Completion: 2018-06

Publications

O'Connor OA, Lue JK, Sawas A, Amengual JE, Deng C, Kalac M, Falchi L, Marchi E, Turenne I, Lichtenstein R, Rojas C, Francescone M, Schwartz L, Cheng B, Savage KJ, Villa D, Crump M, Prica A, Kukreti V, Cremers S, Connors JM, Kuruvilla J. Brentuximab vedotin plus bendamustine in relapsed or refractory Hodgkin's lymphoma: an international, multicentre, single-arm, phase 1-2 trial. Lancet Oncol. 2018 Feb;19(2):257-266. doi: 10.1016/S1470-2045(17)30912-9. Epub 2017 Dec 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bendamustine	Small molecule	60 mg/m2	Intravenous
Subject	Bendamustine	Small molecule	70 mg/m2	Intravenous
Subject	Bendamustine	Small molecule	80 mg/m2	Intravenous
Subject	Bendamustine	Small molecule	90 mg/m2	Intravenous
Subject	Bendamustine	Small molecule	100 mg/m2	Intravenous
Subject	Brentuximab Vedotin	Monoclonal antibody	1.2 mg/kg	Intravenous
Subject	Brentuximab Vedotin	Monoclonal antibody	1.8 mg/kg	Intravenous
Background	Pegfilgrastim	Protein / enzyme biologic	—	—
Background	filgrastim	Protein / enzyme biologic	—	—

Brentuximab Vedotin and Bendamustine for the Treatment of Hodgkin Lymphoma and Anaplastic Large Cell Lymphoma (ALCL)

Summary

Timeline

Publications

Drugs

Indications