Study of Itacitinib for the Prophylaxis of Graft-Versus-Host Disease and Cytokine Release Syndrome After T-cell Replete Haploidentical Peripheral Blood Hematopoietic Cell Transplantation

PHASE1CompletedINTERVENTIONAL
Enrollment

55

Participants

Timeline

Start Date

September 4, 2019

Primary Completion Date

April 26, 2024

Study Completion Date

May 26, 2024

Conditions
Acute Myelogenous LeukemiaAcute Lymphocytic LeukemiaMyelodysplastic SyndromesNon-Hodgkin LymphomaHodgkin Disease
Interventions
PROCEDURE

Stem cell transplantation

Standard of care

DRUG

Itacitinib

Itacitinib may be taken without regard to food.

OTHER

Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT)

"* Screening, day 14, day 28, day 42, day 74, day 100, taper period, and follow-up (pilot study)~* Screening, day 14, day 28, day 42, day 74, day 100, day 180, taper period, and follow-up period (expansion study)"

OTHER

Human Activity Profile

"* Screening, day 14, day 28, day 42, day 74, day 100, taper period, and follow-up (pilot study)~* Screening, day 14, day 28, day 42, day 60, day 74, day 100, day 180, taper period, and follow-up period (expansion study)"

Trial Locations (1)

63110

Washington University School of Medicine, St Louis

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Incyte Corporation

INDUSTRY

collaborator

American Society of Hematology

OTHER

collaborator

National Cancer Institute (NCI)

NIH

lead

Washington University School of Medicine

OTHER