CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 34 enrolled
Drug / intervention
Brentuximab Vedotin +1 moredrug
Likely dose
Brentuximab Vedotin 1.2 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/NCT01534078
NCT01534078Phase 2Completed

Brentuximab Vedotin Plus AVD in Non-bulky Limited Stage Hodgkin Lymphoma

Massachusetts General Hospital·interventional·Posted Feb 16, 2012·Updated Feb 20, 2018

In Brief

A Phase 2 clinical trial evaluating Brentuximab Vedotin and Adriamycin, vinblastine, and dacarbazine for Hodgkin Lymphoma. Completed, enrolled 34 participants across 4 sites.

Detailed Summary

Brentuximab is an antibody-drug conjugate (ADC), which is the combination of an antibody (a protein that binds to cells) and a chemotherapy molecule. Brentuximab works by using the antibody portion to enter into the Hodgkin lymphoma cells and then releasing the chemotherapy portion, which attempts to destroy the cell. The intravenous chemotherapy drugs Adriamycin, Vinblastine and Dacarbazine (AVD) which you will receive in this research study are approved for use in people with Hodgkin Lymphoma. A drug called bleomycin is usually included with AVD, but since it appears to be a less effective drug with significant potential risks, it is being replaced in this study with the drug brentuximab. In this research study, the investigators are looking to see whether brentuximab in combination with AVD is effective in treating limited-stage Hodgkin Lymphoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedFeb 16, 2012
Enrollment StartMar 1, 2012
Primary CompletionJan 1, 2015
Study CompletionJan 1, 2018
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 14.4 years ago

Interventions

Brentuximab Vedotindrug

2 doses administered 14 days apart; followed by combination therapy with AVD for 4-6 cycles; 1.2 mg/kg

Adriamycin, vinblastine, and dacarbazinedrug

Combination therapy with brentuximab for 4-6 cycles; 25 mg/m2 Adriamycin; 6 mg/m2 Vinblastine; 375 mg/m2 Dacarbazine