At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 11 enrolled

Drug / intervention

Bortezomibdrug

Likely dose

Bortezomib 1.3 mg/m2from 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/NCT00408928

NCT00408928Phase 2Completed

Compare CT.gov

Phase II Trial of VELCADE® (Bortezomib) for Steroid Refractory Acute GVHD

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University·interventional·Posted Dec 8, 2006·Updated May 4, 2025

In Brief

A Phase 2 clinical trial evaluating Bortezomib for Graft-versus-Host Disease. Completed, enrolled 11 participants across 1 site.

Detailed Summary

The purpose of this research study is to test the safety and effectiveness of VELCADE® in the treatment of acute graft-versus-host disease (GVHD) that has not responded to steroids or has worsened when the steroid dose was decreased. VELCADE® is a drug that inhibits certain immune reactions that happen when lymphocytes encounter foreign substances. We are doing this research to determine if VELCADE® may be useful in treating GVHD.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsGraft-versus-Host Disease

CountriesUnited States

Collaborators--

Timeline

Phase 2CompletedFinished

2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartNov 2005

First PostedDec 2006

Primary CompletionSep 2008

Study CompletionSep 2009

TodayJul 2026

First PostedDec 8, 2006

Enrollment StartNov 1, 2005

Primary CompletionSep 1, 2008

Study CompletionSep 1, 2009

TodayJul 2, 2026

Enrollment to primary: 2.8 yearsPosted 19.6 years ago

Interventions

Bortezomibdrug

Bortezomib at 1.3 mg/m2/dose given twice weekly for two weeks followed by a 10-day rest period. If patients have a complete response, they will receive additional cycles of bortezomib.