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

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

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 for testing against corticosteroids alone in a subsequent Phase III trial.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
• Collaborators: Blood and Marrow Transplant Clinical Trials Network; National Cancer Institute (NCI)
• Treatments: Denileukin diftitox; Etanercept; Interleukin-2; Mycophenolate mofetil; Mycophenolic Acid; Pentostatin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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