RecruitingLeukemiaMyelodysplasiaChronic Myelomonocytic Leukemia
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
Eligible age
18+ yrs
Accepts
All genders
Locations
3 states
Healthy volunteers
No
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About this study
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).
Sponsor: Hannah Choe, MD
You may qualify if…
- ✓ Age 18.0 years or older at the time of enrollment
- ✓ Patients undergoing allogeneic hematopoietic cell transplantation for one of the following indications:
- ✓ Acute leukemia with no circulating blasts and with less than 5% blasts in the bone marrow
- ✓ Myelodysplasia/chronic myelomonocytic leukemia with no circulating blasts and with less than 10% blasts in the bone marrow (higher blast percentage allowed in MDS due to lack of differences in outcomes with \<5% versus 5-10% blasts in this disease).
- ✓ Planned myeloablative (MAC) conditioning regimen (see eligible regimens in Section 9.2)
- ✓ Patients must have a related or unrelated peripheral blood stem cell donor as follows:
- ✓ Sibling donor must be a 6/6 match for HLA-A and -B at intermediate (or higher) resolution, and -DRB1 at high resolution using DNA-based typing and must be willing to donate peripheral blood stem cells and meet institutional criteria for donation.
- ✓ Unrelated donor must be an 8/8 match at HLA-A, -B, -C and -DRB1 at high resolution using DNA-based typing.
You may not qualify if…
- ✕ Prior allogeneic transplant
- ✕ Active CNS (central nervous system) involvement by malignant cells
- ✕ Patients with secondary acute myeloid leukemia arising from myeloproliferative neoplasms or overlap syndromes, including CMML(chronic myelomonocytic leukemia) and MDS/MPN (myelodysplastic syndromes/myeloproliferative neoplasms) syndromes; patients with secondary acute myeloid leukemia arising from myelodysplastic neoplasm are eligible.
- ✕ Patients with uncontrolled bacterial, viral, or fungal infections (currently taking medication and with progression or no clinical improvement) at time of enrollment.
- ✕ Active or inadequately treated latent infection with Mycobacterium tuberculosis (i.e., TB).
- ✕ Patients seropositive for human immunodeficiency virus (HIV) with detectable viral load. HIV+ patients with an undetectable viral load on antiviral therapy are eligible.
- ✕ Evidence of uncontrolled hepatitis B virus (HBV) or hepatitis C virus (HCV). The study allows:
- ✕ Positive HBV serology with undetectable viral load and ongoing antiviral prophylaxis to prevent potential HBV reactivation.
Where it's recruiting
Source: ClinicalTrials.gov · NCT07249346 · last updated 2026-09-02