At a glance
ClinicalIndex Comparison Record- ✓Prior allogeneic hematopoietic stem cell transplant (bone marrow, peripheral blood stem cells, or cord blood)
- ✓De novo acute GVHD diagnosed within 48 hours prior to enrollment
- ✓No prior systemic immune suppressive therapy for GVHD except maximum 48 hours of corticosteroids (≥1 mg/kg/day methylprednisolone)
- ✓Absolute neutrophil count greater than 500/µL
- ✕ONTAK, pentostatin, or etanercept given within 7 days of enrollment
- ✕Active uncontrolled infection
- ✕Unscheduled donor lymphocyte infusion (DLI) or DLI not part of original transplant plan
- ✕Prior steroid therapy (other indication) at doses ≥0.5 mg/kg/day methylprednisolone within 7 days prior to GVHD onset
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Initial Systemic Treatment of Acute GVHD: A Phase II Randomized Trial Evaluating Etanercept, Mycophenolate Mofetil (MMF), Denileukin Diftitox (ONTAK), and Pentostatin in Combination With Corticosteroids (BMT CTN #0302)
In Brief
A Phase 2 clinical trial evaluating Etanercept, Mycophenolate Mofetil, and 2 other interventions for Graft vs Host Disease and Immune System Disorders. Completed, enrolled 180 participants across 19 sites.
Detailed 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.
Study Details
Timeline
Interventions
Etanercept \[25 mg subcutaneously twice weekly for up to 4 weeks; discontinue if in complete response by 4 weeks\].
Mycophenolate mofetil (MMF) \[20 mg/kg (maximum 1 gm) orally or intravenously twice daily; continue through prednisone taper, then taper MMF over 4 weeks\].
Denileukin Diftitox (ONTAK®) \[9 mcg/kg intravenously Days 1, 3, 5, 15, 17, 19\].
Pentostatin \[1.5 mg/m2 daily for 3 days; Days 1-3 and repeat Days 15-17