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Bortezomib for the Treatment of Refractory Chronic Graft-vs-Host Disease(cGVHD)

NCT01158105 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2016-01-18

No results posted yet for this study

Summary

The purpose of this study is to see if bortezomib (Velcade) is effective in the treatment of refractory cGVHD.

Conditions

  • Chronic Graft-versus-host Disease

Interventions

DRUG

Bortezomib

1.6 mg/m2 IV infusion on days 1, 8, 15, 22 of each 35 day cycle, for up to 6 cycles.Patients who continue to respond during the initial treatment phase with no ongoing significant adverse events will be eligible to receive up to 6 additional cycles.This maintenance dose will be administered on days 1 and 15.

Sponsors & Collaborators

  • Millennium Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Baylor Research Institute

    lead OTHER

Principal Investigators

  • Alan Miller, MD, PhD · Charles A. Caner Center, Baylor University Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2013-05-31
Completion
2017-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01158105 on ClinicalTrials.gov