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NCT05364762 · ClinicalTrials.gov registry record · Phase 2
Adding Itacitinib to Cyclophosphamide and Tacrolimus for the Prevention of Graft Versus Host Disease in Patients Undergoing Hematopoietic Stem Cell Transplants
A Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, sponsored by City of Hope Medical Center.
- Active
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT05364762: Active Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, sponsored by City of Hope Medical Center.
NCT05364762 is a Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome that is active but no longer recruiting, run by City of Hope Medical Center. The registered enrollment target is 20 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05364762, a Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, is active but no longer recruiting, sponsored by City of Hope Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Acute GVHD will be graded and staged according to Mount Sinai Acute GVHD International Consortium (MAGIC) criteria.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- OTHER Quality-of-Life Assessment
- DRUG Itacitinib
- DRUG Tacrolimus
- PROCEDURE Peripheral Blood Stem Cell Transplantation
Study Locations (1)
California
- City of Hope Medical Center - Duarte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2022-11-23 |
| Est. Completion | 2026-05-22 |
| Phase | Phase 2 |
What the registry record for NCT05364762 still lists
NCT05364762 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (83% lower).
The record links to 7 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT05364762 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05364762 about?
NCT05364762 is a clinical study titled "Adding Itacitinib to Cyclophosphamide and Tacrolimus for the Prevention of Graft Versus Host Disease in Patients Undergoing Hematopoietic Stem Cell Transplants". 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, pr...
What is the current status of trial NCT05364762?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2022-11-23. Estimated completion is 2026-05-22.
What conditions does trial NCT05364762 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Myelodysplastic Syndrome, Acute Lymphoblastic Leukemia, Chronic Myelomonocytic Leukemia, Myeloproliferative Neoplasm.
What interventions are being tested in trial NCT05364762?
The interventions under investigation include: Cyclophosphamide (DRUG), Quality-of-Life Assessment (OTHER), Itacitinib (DRUG), Tacrolimus (DRUG), Peripheral Blood Stem Cell Transplantation (PROCEDURE).
Who is sponsoring clinical trial NCT05364762?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05364762 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05364762's enrollment target sits among peer trials
20 246th of 306 higher than 50 of 306 other Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Myeloid Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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