RecruitingPhase 2NCT07249346

Dose-Expansion Study of Low Dose Post-Transplant Cyclophosphamide/Tacrolimus/Ruxolitinib for Graft-versus-Host Disease (GVHD) Prophylaxis in Myeloablative Allogeneic Peripheral Blood Stem Cell Transplantation

An Open Label, Non-Randomized, Multi-Center Pilot Dose-Expansion Study of Low Dose Post-Transplant Cyclophosphamide/Tacrolimus/Ruxolitinib for GVHD Prophylaxis in Myeloablative Allogeneic Peripheral Blood Stem Cell Transplantation


Sponsor

Hannah Choe, MD

Enrollment

124 participants

Start Date

Jun 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This is an open label, non-randomized, multicenter, pilot, dose expansion study of low dose post-transplant cyclophosphamide (25 mg/kg on Days +3 and +4)/tacrolimus/ruxolitinib in the setting of myeloablative conditioning (MAC) allogeneic peripheral blood stem cell transplantation (PBSCT).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a specific combination of drugs — low-dose cyclophosphamide, tacrolimus, and ruxolitinib — given after a stem cell transplant from a donor to prevent graft-versus-host disease (GVHD), a serious complication where the donor's immune cells attack the patient's body. **You may be eligible if...** - You are 18 or older - You have acute leukemia (with fewer than 5% blast cells in bone marrow) or a myelodysplastic syndrome - You are receiving a stem cell transplant from a matched related or unrelated donor using peripheral blood stem cells - Your heart, lung, kidney, and liver function meet specified thresholds - You have a Karnofsky performance score of at least 70% **You may NOT be eligible if...** - You have had a prior bone marrow or stem cell transplant - You have active cancer in the brain or spinal fluid - You have an uncontrolled infection (bacterial, viral, or fungal) - You have active or poorly treated tuberculosis - You have uncontrolled HIV with detectable viral load, or active hepatitis B or C - You had a heart attack, stroke, or dangerous blood clot in the past 6 months - You have severe heart failure - You are pregnant or breastfeeding - You have previously been treated with ruxolitinib or immune checkpoint inhibitor drugs within the past 6 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRuxolitinib

Taken PO

DRUGMyeloablative conditioning regimen

Patients will receive a full-intensity myeloablative conditioning regimen. Allowed regimens include: * Flu/Bu(130 mg/m2/day x 4 days) * Flu/TBI (8-12Gy) * Flu/Bu/Thiotepa The addition of alemtuzumab or ATG is not allowed.

PROCEDUREHematopoietic Stem Cell Transplantation

Patients will undergo HCT

DRUGCyclophosphamide

Given IV

DRUGTacrolimus

Given PO


Locations(1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

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NCT07249346


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