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COMPLETED
NCT01657331
PHASE1/PHASE2

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

Sponsor: Columbia University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

65

Start Date

2012-07

Completion Date

2018-06

Last Updated

2026-06-24

Healthy Volunteers

No

Interventions

DRUG

Brentuximab Vedotin

Dose escalation in phase I of the study from 1.2-1.8 mg/kg, IV infusions over 30 minutes on day 1 of each 21-day cycle.

DRUG

Bendamustine

Dose escalation in phase I of the study from 60-100 mg/m2, IV infusion on days 1 and 2 of each 21-day cycle.

DRUG

Neulasta

(Non-experimental) Standard procedure prophylactic pegfilgrastim on day 3 of any subsequent cycle after cycle 1, or filgrastim for 5 to 10 days, per investigator's discretion.

Locations (3)

Center for Lymphoid Malignancies at CUMC

New York, New York, United States

British Columbia Cancer Agency

Vancouver, British Columbia, Canada

Princess Margaret Hospital

Toronto, Ontario, Canada