Actively Recruiting
Ruxolitinib With and Without CTLA-4 Ig Abatacept for the Prophylaxis of Graft-Versus-Host Disease and Cytokine Release Syndrome After T-cell Replete Haploidentical Peripheral Blood Hematopoietic Cell Transplantation
Led by Washington University School of Medicine · Updated on 2026-04-22
41
Participants Needed
1
Research Sites
185 weeks
Total Duration
On this page
Sponsors
W
Washington University School of Medicine
Lead Sponsor
I
Incyte Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Allogeneic hematopoietic cell transplantation (HCT) is one of the only curative intent therapies available for hematologic malignancies. HLA-matched sibling donors have historically offered the best clinical results but are unavailable for the majority of patients, while most patients do have readily available haploidentical donors. One of the risks of a haploidentical HCT is graft vs. host disease (GVHD), but it is difficult to reduce the incidence of GVHD without compromising the graft vs. leukemia (GVL) effect. The hypothesis of this study is that JAK inhibition with and without CTLA-4 Ig with haploidentical HCT may mitigate GVHD and cytokine release syndrome while retaining the GVL effect and improving engraftment.
CONDITIONS
Official Title
Ruxolitinib With and Without CTLA-4 Ig Abatacept for the Prophylaxis of Graft-Versus-Host Disease and Cytokine Release Syndrome After T-cell Replete Haploidentical Peripheral Blood Hematopoietic Cell Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of one of the specified hematological malignancies such as AML, ALL, myelodysplastic syndrome, NHL, Hodgkin lymphoma, or myelofibrosis
- Planned T cell-replete peripheral blood haploidentical donor transplantation
- Available HLA-haploidentical donor who is a blood-related family member, at least 18 years old, in general good health, with no active hepatitis, negative for HTLV and HIV, and not pregnant
- ECOG performance status of 2 or less
- Adequate organ function including bilirubin, liver enzymes, creatinine, oxygen saturation, heart and lung function within specified limits
- Able to receive GVHD prophylaxis with tacrolimus, mycophenolate mofetil (if applicable), and cyclophosphamide
- At least 18 years old at the time of consent
- Agreement to use adequate contraception if of childbearing potential
- Able to understand and willing to sign informed consent
You will not qualify if you...
- Prior allogeneic transplant
- Presence of donor specific antibodies with high mean fluorescence intensity
- Known HIV or active hepatitis B or C infection or active tuberculosis
- Known hypersensitivity to study drugs
- Planning to receive antithymocyte globulin as part of conditioning
- Use of investigational drugs within 14 days prior to study drug
- Pregnant or breastfeeding; women of childbearing potential must have a negative pregnancy test within 14 days prior to Day -3
- Uncontrolled illness such as active infection, autoimmune disease, heart failure, unstable angina, or arrhythmias
- Use of immunosuppressive doses of steroids (except for adrenal insufficiency)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
Research Team
R
Ramzi Abboud, M.D.
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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