CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 22 enrolled
Drug / intervention
bortezomib +1 moredrug
Likely dose
bortezomib 1.3 mgfrom 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/NCT00815919
NCT00815919Phase 2Completed
CompareCT.gov

A Phase II Trial of Bortezomib (Velcade) Plus Prednisone for Initial Therapy of Chronic Graft Versus Host Disease

Dana-Farber Cancer Institute·interventional·Posted Dec 31, 2008·Updated Jul 22, 2015

In Brief

A Phase 2 clinical trial evaluating bortezomib and Prednisone for Chronic Graft Versus Host Disease. Completed, enrolled 22 participants across 1 site.

Detailed Summary

The purpose of this research study is to determine the effectiveness of bortezomib (Velcade) plus prednisone for treating chronic graft versus host disease (cGVHD) and the safety of this drug combination in this patient population. Chronic GVHD is a medical condition that may occur after allogeneic stem cell transplantation. The donor's immune system may recognize the participants body (the host) as foreign and attempt to "reject" it. Bortezomib has been used in other research studies, and information from those studies suggests that this drug may help to control the abnormal immune responses that underlie cGVHD.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Graft Versus Host Disease
CountriesUnited States
CollaboratorsMillennium Pharmaceuticals, Inc.

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 31, 2008
Enrollment StartDec 1, 2008
Primary CompletionJan 1, 2012
Study CompletionJan 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 17.5 years ago

Interventions

bortezomibdrug

Given intravenously at a dose of 1.3 mg/m\^2 once a week for the first four weeks of a five week cycle for a total of 3 cycles

Prednisonedrug

Taken orally once a day at a dose of 0.5-1 mg/kg. Dose reduction may be initiated after 1 cycle of therapy. A suggested taper is 10-25% every 1-2 weeks.