drugset / Trial / NCT04339101
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
NaSingle-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2020-11-11
- Primary completion
- 2023-05-22
- Completion
- 2025-10-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Itacitinib | Small molecule | — | Oral |
| Background | Fludarabine | Small molecule | — | Other |
| Background | Melphalan | Small molecule | — | Intravenous |
| Background | Sirolimus | Small molecule | — | Oral |
| Background | Tacrolimus | Small molecule | — | Intravenous |