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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 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.

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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.

Conditions Studied

Acute Myeloid Leukemia Myelodysplastic Syndrome Acute Lymphoblastic Leukemia Chronic Myelomonocytic Leukemia Myeloproliferative Neoplasm Primary Myelofibrosis Secondary Myelofibrosis

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

FieldValue
Enrollment Target 20 participants
Start Date 2022-11-23
Est. Completion 2026-05-22
Phase Phase 2

Sponsor

City of Hope Medical Center

582 total trials

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What the Registry Record Tells You About NCT05364762

The ClinicalTrials.gov registry entry for NCT05364762 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (83% lower). The listed sponsor is City of Hope Medical Center, which has 582 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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