At a glance
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Phase IIa Study of Addition of Itacitinib With Tacrolimus/Sirolimus Regimen for GVHD Prophylaxis in Fludarabine and Melphalan Non-Myeloablative Conditioning Hematopoietic Cell Transplantation for Acute Leukemias, MDS or MF
In Brief
A Phase 2 clinical trial evaluating Fludarabine, Itacitinib Adipate, and 5 other interventions for Acute Leukemia and 4 related conditions. Completed, enrolled 59 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Given via infusion
Given PO
Given IV
Ancillary studies
Ancillary studies
Given PO
Given IV or PO