Actively Recruiting
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
Led by Hannah Choe, MD · Updated on 2025-12-24
124
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
H
Hannah Choe, MD
Lead Sponsor
I
Incyte Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at enrollment
- Undergoing allogeneic hematopoietic cell transplantation for acute leukemia with no circulating blasts and less than 5% blasts in bone marrow
- Undergoing transplantation for myelodysplasia or chronic myelomonocytic leukemia with no circulating blasts and less than 10% blasts in bone marrow
- Planned myeloablative conditioning regimen using Flu/Bu, Flu/TBI, or Flu/Bu/Thiotepa without alemtuzumab or ATG
- Having a related sibling donor with 6/6 HLA match or an unrelated donor with 8/8 HLA match who meets donation criteria
- Left ventricular ejection fraction of at least 45%
- Estimated creatinine clearance greater than 60 ml/min
- Pulmonary function with DLCO corrected for hemoglobin at least 60% and FEV1 predicted at least 60%
- Liver function with AST/ALT less than 3 times upper limit of normal and total bilirubin less than 2 mg/dL (excluding Gilbert's syndrome or hemolysis)
- Karnofsky Performance Score of at least 70%
- Female patients must agree to two effective contraception methods or abstinence from consent through 12 months post-transplant unless postmenopausal or surgically sterilized
- Male patients must agree to barrier contraception or abstinence from consent through 12 months post-transplant
- Planned use of certain approved targeted maintenance therapies only
- Voluntary written informed consent obtained
You will not qualify if you...
- Prior allogeneic transplant
- Active central nervous system involvement by malignant cells
- Secondary acute myeloid leukemia from myeloproliferative neoplasms or overlap syndromes
- Uncontrolled bacterial, viral, or fungal infections at enrollment
- Active or inadequately treated latent tuberculosis infection
- Detectable HIV viral load (HIV+ with undetectable viral load allowed)
- Uncontrolled hepatitis B or C infection
- Recent arterial or venous thrombosis within 6 months or severe heart conditions
- Pregnancy or lactation
- Serious medical or psychiatric illness interfering with study participation
- Prior malignancies not meeting criteria for remission or approval
- Planned use of ATG or alemtuzumab in conditioning
- Planned prophylactic donor leukocyte infusions
- Prior use of ruxolitinib
- Use of immune checkpoint inhibitors within 6 months prior to conditioning
- History of congenital Long QT syndrome
AI-Screening
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Trial Site Locations
Total: 1 location
1
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
T
The Ohio State University Comprehensive Cancer Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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