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

PHASE2Active, not recruitingINTERVENTIONAL

Enrollment

Participants

Timeline

Start Date

November 11, 2020

Primary Completion Date

May 22, 2023

Study Completion Date

January 20, 2026

Conditions

Acute LeukemiaHematologic and Lymphocytic DisorderMyelodysplastic SyndromePrimary MyelofibrosisSecondary Myelofibrosis

Interventions

DRUG

Fludarabine

Given via infusion

DRUG

Itacitinib Adipate

Given PO

DRUG

Melphalan

Given IV

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

DRUG

Sirolimus

Given PO

DRUG

Tacrolimus

Given IV or PO

Trial Locations (1)

City of Hope Medical Center, Duarte

All Listed Sponsors

collaborator

National Cancer Institute (NCI)

NIH

lead

City of Hope Medical Center

OTHER