Itacitinib, Tacrolimus, and Sirolimus for the Prevention of GVHD in Patients With Acute Leukemia, Myelodysplastic Syndrome, or Myelofibrosis Undergoing Reduced Intensity Conditioning Donor Stem Cell Transplantation | Aplastic Anemia & MDS International Foundation
Itacitinib, Tacrolimus, and Sirolimus for the Prevention of GVHD in Patients With Acute Leukemia, Myelodysplastic Syndrome, or Myelofibrosis Undergoing Reduced Intensity Conditioning Donor Stem Cell Transplantation

Clinical Trial: NCT04339101

For more details on this clinical trial, including contact information, please see this trial’s listing on clinicaltrials.gov:
Purpose: 

This phase IIa trial studies the side effects of itacitinib when given together with standard treatment (tacrolimus and sirolimus), and to see how well it works in preventing graft-versus-host-disease (GVHD) in patients with acute leukemia, myelodysplastic syndrome or myelofibrosis who are undergoing reduced intensity conditioning donor stem cell transplantation. GVHD is a common complication after donor stem cell transplantation, resulting from donor immune cells recognizing recipients' cells and attacking them. Adding itacitinib to tacrolimus and sirolimus may reduce the risk GVHD and ultimately improve overall outcome and survival after donor stem cell transplantation.

Status: 
Not yet recruiting
Study Date: 
Mon, 06/01/2020 to Wed, 03/09/2022
Bone Marrow Disease(s): 
  • acute myeloid leukemia (AML)
  • myelodysplastic syndromes (MDS)
Intervention: 
Drug: Fludarabine Drug: Itacitinib Adipate Drug: Melphalan Other: Quality-of-Life Assessment Other: Questionnaire Administration Drug: Sirolimus Drug: Tacrolimus