Bortezomib for the Treatment of Refractory Chronic Graft-vs-Host Disease(cGVHD)
|ClinicalTrials.gov Identifier: NCT01158105|
Recruitment Status : Unknown
Verified January 2016 by Baylor Research Institute.
Recruitment status was: Active, not recruiting
First Posted : July 8, 2010
Last Update Posted : January 18, 2016
|Condition or disease||Intervention/treatment||Phase|
|Chronic Graft-versus-host Disease||Drug: Bortezomib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 2 Study of Bortezomib (Velcade) for the Treatment of Steroid Refractory Chronic Graft-vs-Host Disease|
|Study Start Date :||June 2010|
|Actual Primary Completion Date :||May 2013|
|Estimated Study Completion Date :||January 2017|
1.6 mg/m2 intravenous infusion will be administered 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.
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.
Other Name: Velcade
- To evaluate the effectiveness and safety of the proteasome inhibitor Bortezomib (Velcade) in the treatment of steroid refractory chronic Graft-vs-Host Disease (cGVHD) [ Time Frame: 19 months ]Total time frame including treatment and follow up is 19 months(Maximum of 6 cycles during initial treatment phase, 6 cycles in maintenance phase, and follow up phase for 6 months). Subjects will be assessed for signs and symptoms of cGVHD on day 1 of every cycle using standardized criteria for diagnosis of cGVHD, new clinical scoring system, and new guidelines for global assessment of chronic GVHD severity per NIH consensus development project on criteria for clinical trials in chronic GVHD. Safety will be assessed in terms of adverse events for 30 days following the last dose to a maximum of 6 months. Adverse events will be recorded through out the trial and will be followed by investigator until resolution.
- To examine blood cells from patients who develop steroid resistant cGVHD following allogeneic HSCT for disease related gene signatures using DNA microarray analysis techniques [ Time Frame: 12 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01158105
|United States, Texas|
|Charles A. Cancer Center, Baylor University Medical Center|
|Dallas, Texas, United States, 75246|
|Principal Investigator:||Alan Miller, MD, PhD||Charles A. Caner Center, Baylor University Medical Center|