Treatment for Acute Graft-Versus-Host Disease (BMT CTN 0302)

Completed · Phase 2

Conditions studied: Graft vs Host Disease, Immune System Disorders

In brief

The study is a randomized Phase II, four arm treatment trial. The primary purpose of the study is to define new agents with promising activity against acute graft-versus-host disease (GVHD) suitable for testing against corticosteroids alone in a subsequent Phase III trial.

Key facts

Study ID

NCT00224874

Run by

National Heart, Lung, and Blood Institute (NHLBI)

People needed

180

Starts

2005-09-01

Expected to finish

2012-06-01

Last updated by the study team

2021-11-01

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Prior allogeneic hematopoietic stem cell transplant using either bone marrow, peripheral blood stem cells, or cord blood
• De novo acute GVHD diagnosed within 48 hours prior to enrollment; biopsy confirmation of GVHD is strongly recommended but not required; enrollment should not be delayed awaiting biopsy or pathology results; the patient must have had no previous systemic immune suppressive therapy given for treatment of acute GVHD except for a maximum 48 hours of prior corticosteroid therapy (at least 1 mg/kg/day methylprednisolone)
• Patients that have undergone a scheduled donor lymphocyte infusion (DLI) as part of their original transplant therapy plan
• Absolute neutrophil count (ANC) greater than 500/µL
• Clinical status at enrollment to allow tapering of steroids to not less than 1 mg/kg/day methylprednisolone (1.4 mg/kg/day prednisone) at Day 28 of therapy (e.g., persisting malignant disease suggesting the need for accelerated taper of immunosuppression)
• Estimated creatinine clearance greater than 30 mL/minute
• Assent and educational materials provided to, and reviewed with, patients under the age of 18

You may not qualify if…

• ONTAK, pentostatin, or etanercept given within 7 days of enrollment
• Active uncontrolled infection
• Patients that have undergone an unscheduled DLI, or DLI that was not part of their original transplant therapy plan
• If any prior steroid therapy (for indication other than GVHD), treatment at doses of at least 0.5 mg/kg/day methylprednisolone within 7 days prior to onset of GVHD
• Patients unlikely to be available at the transplant center on Day 28 and 56 of therapy
• A clinical syndrome resembling de novo chronic GVHD developing at any time after allotransplantation (see Chapter 2 of the BMT CTN Manual of Procedures for details of de novo chronic GVHD)
• Other investigational therapeutics for GVHD within 30 days, including agents used for GVHD prophylaxis
• Patients who are pregnant, breast feeding, or if sexually active, unwilling to use effective birth control for the duration of the study
• Adults unable to provide informed consent
• Patients with a history of intolerance to any of the study drugs

Where it is running

• City of Hope National Medical Center — Duarte, California, United States
• University of California — San Diego, California, United States
• Stanford Hospital and Clinics — Stanford, California, United States
• University of Florida College of Medicine (Shands) — Gainesville, Florida, United States
• Johns Hopkins/SKCCC — Baltimore, Maryland, United States
• DFCI/Brigham & Women's Hospital — Boston, Massachusetts, United States
• University of Michigan Medical Center — Ann Arbor, Michigan, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Washington University/Barnes Jewish Hospital — St Louis, Missouri, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States
• Duke University Medical Center (Peds) — Durham, North Carolina, United States
• University Hospitals of Cleveland/Case Western — Cleveland, Ohio, United States
• Oregon Health Sciences University — Portland, Oregon, United States
• University of Pennsylvania Cancer Center — Philadelphia, Pennsylvania, United States
• University of Texas/MD Anderson CRC — Houston, Texas, United States
• Texas Transplant Institute — San Antonio, Texas, United States
• Fred Hutchinson Cancer Research Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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