At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 35 enrolled

Drug / intervention

Bortezomib +2 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/NCT01323920

NCT01323920Phase 2Completed

Compare CT.gov

Bortezomib-based Graft-Versus-Host-Disease Prophylaxis After Myeloablative Allogeneic Stem Cell Transplantation for Patients Lacking HLA-matched Related Donors: A Phase 2 Study

Dana-Farber Cancer Institute·interventional·Posted Mar 28, 2011·Updated May 30, 2017

In Brief

A Phase 2 clinical trial evaluating Bortezomib, Tacrolimus, and 1 other intervention for Leukemia and 2 related conditions. Completed, enrolled 35 participants across 1 site.

Detailed Summary

A common problem after stem cell transplant is graft-versus-host-disease (GVHD). GVHD is a complication of transplantation where the donor graft attacks and damages some of your tissues. After stem cell transplant, all patients receive prophylactic medications against GVHD. In this research study, we are studying the safety and effectiveness of a bortezomib based GVHD prophylaxic drug combination in participants after myeloablative allogeneic stem call transplantation from a matched unrelated donor, mismatched related or unrelated donor.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsLeukemia, Lymphoma, Myelodysplastic Syndrome

CountriesUnited States

Collaborators--

Timeline

Phase 2CompletedFinished

2011201220132014201520162017201820192020202120222023202420252026

First PostedMar 2011

Enrollment StartMay 2011

Primary CompletionFeb 2013

Study CompletionNov 2013

TodayJul 2026

First PostedMar 28, 2011

Enrollment StartMay 1, 2011

Primary CompletionFeb 1, 2013

Study CompletionNov 1, 2013

TodayJul 2, 2026

Enrollment to primary: 1.8 yearsPosted 15.3 years ago

Interventions

Bortezomibdrug

Bortezomib 1.3 mg/m\^2 IV

Tacrolimusdrug

Tacrolimus 0.05 mg/kg PO bid

Methotrexatedrug

Methotrexate 15 mg/m\^2 IV