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ACTIVE NOT RECRUITING
NCT05364762
PHASE2

Adding Itacitinib to Cyclophosphamide and Tacrolimus for the Prevention of Graft Versus Host Disease in Patients Undergoing Hematopoietic Stem Cell Transplants

Sponsor: City of Hope Medical Center

View on ClinicalTrials.gov

Summary

This clinical trial evaluates the safety and effectiveness of adding itacitinib to cyclophosphamide and tacrolimus for the prevention of graft versus host disease (GVHD) in patients undergoing hematopoietic stem cell transplant. Itacitinib is an enzyme inhibitor that may regulate the development, proliferation, and activation of immune cells important for GVHD development. Cyclophosphamide and tacrolimus are immunosuppressive agents that may prevent GVHD in patients who receive stem cell transplants. Giving itacitinib in addition to cyclophosphamide and tacrolimus may be more effective at preventing GVHD in patients receiving hematopoietic stem cell transplants.

Official title: Single Center Pilot Study to Investigate the Efficacy of Adding Itacitinib to Post-Transplant Cyclophosphamide as Graft-Versus-Host Disease Prophylaxis After Reduced Intensity Conditioning Matched Donor Hematopoietic Cell Transplantation With Peripheral Blood Stem Cells as Graft Source

Key Details

Gender

All

Age Range

Any - 80 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2022-11-23

Completion Date

2026-05-22

Last Updated

2025-05-30

Healthy Volunteers

No

Interventions

DRUG

Cyclophosphamide

Given IV

DRUG

Itacitinib

Given PO

PROCEDURE

Peripheral Blood Stem Cell Transplantation

Undergo peripheral blood stem cell infusion

OTHER

Quality-of-Life Assessment

Ancillary studies

DRUG

Tacrolimus

Given IV or PO

Locations (1)

City of Hope Medical Center

Duarte, California, United States