CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 55 enrolled
Drug / intervention
brentuximab vedotin +1 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/NCT01874054
NCT01874054Phase 2Completed
CompareCT.gov

A Phase 1/2 Single-arm, Open-label Study to Evaluate the Safety and Efficacy of Brentuximab Vedotin in Combination With Bendamustine in Patients With Relapsed or Refractory Hodgkin Lymphoma (HL)

Seagen Inc.·interventional·Posted Jun 10, 2013·Updated Feb 12, 2019

In Brief

A Phase 2 clinical trial evaluating brentuximab vedotin and bendamustine for Hodgkin Disease. Completed, enrolled 55 participants across 13 sites.

Detailed Summary

The purpose of this study is to assess safety and efficacy of brentuximab vedotin in combination with bendamustine in patients with relapsed or refractory Hodgkin lymphoma. It is an open-label, 2-stage study designed to determine the recommended dose level of bendamustine in combination with brentuximab vedotin. The study will assess the safety profile of the combination treatment and determine what proportion of patients achieve a complete remission.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHodgkin Disease
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJun 10, 2013
Enrollment StartJun 1, 2013
Primary CompletionDec 1, 2015
Study CompletionFeb 20, 2018
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 13.1 years ago

Interventions

brentuximab vedotindrug

1.8 mg/kg every 3 weeks by intravenous (IV) infusion

bendamustinedrug

90 mg/m2 on Days 1 and 2 of 3-week cycles