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

Official Title

A Phase I/II Clinical Trial of the Combination of Brentuximab Vedotin and Bendamustine in Patients With Relapsed or Refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma


This is a phase 1/2 multicentre 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 Centre (CUMC) and at two subsites in Canada.

Trial Description

Primary Outcome:

  • Maximum tolerated dose (MTD) of brentuximab vedotin and bendamustine (phase 1)
  • Dose limiting toxicities (DLT) of brentuximab vedotin and bendamustine (phase 1)
  • Overall Response Rate for the combination of brentuximab vedotin and bendamustine (phase 2)
Secondary Outcome:
  • Duration of Response (DoR) (phase 1)
  • Progression free survival (PFS) (phase 1)
  • Overall Survival (OS) (phase 2)
Brentuximab vedotin will be administered as an outpatient IV infusion on day 1 of each 21-day cycle. Bendamustine will be given as an outpatient infusion on days 1 and 2 of a 21-day cycle. Patients may receive prophylactic pegfilgrastim on day 3 of each cycle, or filgrastim for 5 to 10 days, per investigator's discretion. Patients can receive a maximum of 6 cycles of therapy.

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Canadian Cancer Society

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