Brentuximab Vedotin for Steroid Refractory GvHD

Status: Recruiting
Phase: Phase 1
Diagnosis: Graft-versus-Host-Disease
NCT ID: NCT01596218 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-094

 

This research study is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational drug. Phase I studies also try to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the drug is still being studied and that research doctors are trying to find out more about it. It also means that the FDA has not approved brentuximab vedotin for the treatment of GVHD. Currently, corticosteroids are the standard/first line of treatment for people with GVHD. However, some patients do not achieve a good response with steroids and other experience flare-ups while tapering steroid treatment. Corticosteroid treatment has also led to a weakening of the immune system. For this reason, there have been increased attempts by researchers to find other options for the treatment of Graft vs. Host Disease. Brentuximab vedotin is a drug that is FDA approved for the treatment of certain types of cancers, like Hodgkin's lymphoma. Recent research studies have found increased levels of protein called CD30 in people with acute GVHD. Brentuximab vedotin is designed to target CD30. Researchers have never tried to target the CD30 molecule for the treatment of GVHD, but results from other research studies show that it could help slow the growth of your disease. In this research study, we are trying to determine the safest dose of brentuximab vedotin that can be given to patients with GVHD.

 

Conducting Institutions:
Massachusetts General Hospital, Dana-Farber Cancer Institute, Brigham and Women's Hospital

Overall PI:
Yi-Bin Chen, MD, Massachusetts General Hospital

Site-responsible Investigators:
Corey Cutler, MD, Dana-Farber Cancer Institute

Contacts:
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

Inclusion Criteria: - Acute GVHD - Corticosteroid refractory Exclusion Criteria: - Pregnant or breastfeeding - Requiring mechanical ventilation - Concurrent hepatic VOD - Have received another study agent within 7 days
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