Status:
COMPLETED
Treatment for Acute Graft-Versus-Host Disease (BMT CTN 0302)
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsors:
National Cancer Institute (NCI)
Blood and Marrow Transplant Clinical Trials Network
Conditions:
Graft vs Host Disease
Immune System Disorders
Eligibility:
All Genders
2+ years
Phase:
PHASE2
Brief Summary
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 f...
Detailed Description
BACKGROUND: Acute graft-versus-host disease (GVHD) is the major complication of allogeneic hematopoietic stem cell (HSC) transplantation. Acute GVHD produces significant morbidity and complicates pat...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT00224874
Start Date
September 1 2005
End Date
June 1 2012
Last Update
November 1 2021
Active Locations (19)
Enter a location and click search to find clinical trials sorted by distance.
1
City of Hope National Medical Center
Duarte, California, United States, 91010
2
University of California
San Diego, California, United States, 92093
3
Stanford Hospital and Clinics
Stanford, California, United States, 94305
4
University of Florida College of Medicine (Shands)
Gainesville, Florida, United States, 32610