drugset / Trial / NCT05364762
Adding Itacitinib to Cyclophosphamide and Tacrolimus for the Prevention of Graft Versus Host Disease in Patients Undergoing Hematopoietic Stem Cell Transplants
Phase 2
Active not recruiting
20 enrolled
City of Hope Medical Center
National Cancer Institute (NCI) · collab
NaSingle-groupOpen-labelPrevention
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.
Timeline
- Start
- 2022-11-23
- Primary completion
- 2027-03-25
- Completion
- 2027-03-25
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cyclophosphamide | Other / unclassified | — | Intravenous |
| Subject | Itacitinib | Small molecule | — | Oral |
| Subject | Tacrolimus | Small molecule | — | Intravenous |