CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 65 enrolled
Drug / intervention
Brentuximab Vedotin +2 moredrug
Likely dose
Brentuximab Vedotin 1.8 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01657331
NCT01657331Phase 2Completed

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

Columbia University·interventional·Posted Aug 6, 2012·Updated Jun 24, 2026

In Brief

A Phase 2 clinical trial evaluating Brentuximab Vedotin, Bendamustine, and 1 other intervention for Hodgkin Lymphoma and Anaplastic Large Cell Lymphoma. Completed, enrolled 65 participants across 3 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 6, 2012
Enrollment StartJul 1, 2012
Primary CompletionJun 1, 2018
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 13.9 years ago

Interventions

Brentuximab Vedotindrug

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.

Bendamustinedrug

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.

Neulastadrug

(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.