Brentuximab Vedotin for Steroid Refractory GvHD

Description

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.

Study Start Date

July 2012

Estimated Completion Date

December 2016

Interventions

  • Drug: Brentuximab Vedotin

Specialties

  • Internal Medicine: Clinical Pharmacology,Hematology/Oncology
  • Oncology: BMT/SCT,Pharmacology/Therapy
  • Pharmacy: Chemotherapy/Oncology

MeSH Terms

  • Brentuximab Vedotin
  • Graft vs Host Disease

Study ID

Massachusetts General Hospital -- 12-094

Status

Unknown

Trial ID

NCT01596218

Study Type

Interventional

Trial Phase

Phase 1

Enrollment Quota

28

Sponsor

Massachusetts General Hospital

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (4)

Study Location Distance Name Phone Email
DanaFarber Cancer Institute - Boston, Massachusetts 2.6 miles Corey Cutler MD 617-632-5946 cscutler@partners.org
Brigham and Womens Hospital - Boston, Massachusetts 2.6 miles None None None
DanaFarber Cancer Institute - Boston, Massachusetts 2.6 miles None None None
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles None None None

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