Itacitinib + Tacrolimus + Sirolimus (GVHD prophylaxis)

Current understanding

To be populated as evidence accumulates.

Foundation — FDA Awards $18 Million in Grants for Advancing Treatment of Rare Diseases: cross-connection with cd24fc-gvhd-prevention-mpn: Both target GVHD prophylaxis in allo-transplant recipients including MPN patients, offering distinct mechanistic angles (Siglec-10/DAMP modulation vs JAK1/calcineurin/mTOR inhibition). (novelty: 3)
2026-02-19 — Ruxolitinib Before, During and After Hematopoietic Cell Transplant in Older Patients With Myelofibrosis and Myelodysplastic Syndrome/Myeloproliferative Neoplasm Overlap Syndromes: A parallel phase II trial pairing ruxolitinib with tacrolimus/methotrexate for peri-transplant GVHD prophylaxis in older MF and MDS/MPN overlap patients offers a comparator design to itacitinib + tacrolimus/sirolimus, with both protocols testing JAK inhibitors layered on calcineurin-inhibitor backbones (trial-early). (novelty: 3)
2026-03-30 — 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: Phase IIa trial (trial-early) evaluating itacitinib (JAK1-selective inhibitor) added to standard tacrolimus/sirolimus backbone for GVHD prophylaxis after RIC allogeneic SCT in acute leukemia, MDS, or myelofibrosis — extends the JAK-inhibitor-for-GVHD-prophylaxis concept (ruxolitinib precedent) to a more selective JAK1 agent. (novelty: 3)