Emapalumab With Post-Transplant Cyclophosphamide, Tacrolimus and Mycophenolate Mofetil for the Prevention of Graft-versus-Host Disease After Donor Reduced-Intensity Hematopoietic Cell Transplant

This phase I trial tests the safety, side effects and effectiveness of emapalumab with post-transplant cyclophosphamide, tacrolimus, and mycophenolate mofetil in preventing graft-versus-host disease (GVHD) in patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) after reduced-intensity donor (allogeneic) hematopoietic cell transplant (HCT). Giving chemotherapy, such as fludarabine, melphalan, or busulfan, before a donor \[peripheral blood stem cell\] transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cell

Trial Details

NCT ID
NCT06996119
Phase
PHASE1
Sponsor
City of Hope Medical Center
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Biospecimen Collection
  • Busulfan
  • Computed Tomography
  • Cyclophosphamide
  • Echocardiography Test
  • Emapalumab
Locations (sample)
  • Duarte, California, United States|34.13945,-117.97729

Key Eligibility Criteria

  • Documented informed consent of the participant and/or legally authorized representative
  • Assent, when appropriate, will be obtained per institutional guidelines
  • Age: ≥ 18 years and ≤ 75 years
  • Note: Patients \> 70 years of age must have Karnofsky performance status ≥ 80% and HCT-comorbidity index (CI) ≤ 2

For full eligibility, visit ClinicalTrials.gov.

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