At a glance
ClinicalIndex Comparison Record- ✓Age 1-60 years and candidate for myeloablative donor stem cell transplantation
- ✓Myeloablative regimen using fludarabine and busulfan
- ✓For related donors: 5/6 HLA match at A, B, DRB1 loci (6/6 NOT eligible). For unrelated donors: 5/6 or 6/6 match at A, B, DRB1 loci
- ✓HLA typing at mid-resolution DNA level for A and B loci; high-resolution DNA sequencing for DRB1
- ✕Not a candidate for myeloablative conditioning regimen per current BMT program clinical guidelines
- ✕Patient has 6/6 HLA-matched related donor
- ✕Karnofsky or Lansky performance status <60% at time of HSCT admission
- ✕Evidence of HIV infection or other opportunistic infections (tuberculosis, histoplasmosis, etc.)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The Addition of Etanercept to Standard GVHD Prophylaxis in Patients Undergoing a Full Intensity Allogeneic Hematopoietic Stem Cell Transplant for the Prevention of Transplant Related Complications
In Brief
A Phase 2 clinical trial evaluating Etanercept for Graft-Versus-Host Disease. Completed, enrolled 100 participants across 2 sites.
Detailed Summary
This is a clinical trial to see if the addition of etanercept to standard preventative medicines helps in preventing two major complications of hematopoietic stem cell transplantation (HSCT): decrease the rate of acute graft-vs-host disease (GVHD) and the risk of death.
Study Details
Timeline
Interventions
Etanercept 0.4 mg/kg per dose \[maximum dose 25 mg\] SC for prophylaxis. To start in the 24 hour time period along with the initiation of the preparative regimen for the stem cell transplant. Etanercept will be administered twice weekly until day +56 (8 weeks) post transplant.