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

Recruiting now · Phase 1

Conditions studied: Graft Vs Host Disease, Graft-versus-host-disease, Graft Versus Host Disease

In brief

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.

Key facts

Study ID: NCT06008808
Run by: Washington University School of Medicine
People needed: 41
Starts: 2024-05-07
Expected to finish: 2027-11-27
Last updated by the study team: 2026-04-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients must meet the following criteria within 30 days prior to Day -3 unless otherwise noted.
Diagnosis of one of the hematological malignancies listed below:
Acute myelogenous leukemia (AML) in complete morphological remission, complete remission with incomplete hematologic recovery, and complete remission with partial hematologic recovery (based on ELN Criteria47).
Acute lymphocytic leukemia (ALL) in complete morphological remission (MRD negative by flow cytometry with sensitivity to ≤ 10-4).
Myelodysplastic syndrome with ≤ 10% blasts in bone marrow.
Non-Hodgkin lymphoma (NHL) or Hodgkin lymphoma (HD) in second or greater complete or partial remission.
Myelofibrosis with ≤ 10% blasts in bone marrow. Up to five patients with myelofibrosis will be permitted in Regimen 1 and up to five in Regimen 2.
AML in partial response. One patient will be enrolled in Regimen 1 given the prospect of potential benefit.
Planned treatment is T cell-replete peripheral blood haploidentical donor transplantation.
Available HLA-haploidentical donor who meets the following criteria:
Blood-related family member, including (but not limited to) sibling, offspring, cousin, nephew, or parent. Younger donors should be prioritized.
At least 18 years of age.
HLA-haploidentical donor/recipient match by at least low-resolution typing per institutional standards.
In the investigator's opinion, is in general good health and medically able to tolerate leukapheresis required for harvesting hematopoietic stem cells.
No active hepatitis.
Negative for HTLV and HIV.
Not pregnant.
Donor selection will be in compliance with FDA guidelines as provided in 21 CFR 1271 for donor eligibility https://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Tissue/UCM091345.pdf
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
Adequate organ function as defined below:
Total bilirubin ≤ 1.5 x IULN.
AST (SGOT) and ALT (SGPT) ≤ 3.0 x IULN.
Creatinine ≤ 1.5 x IULN OR creatinine clearance ≥ 45 mL/min/1.73 m2 by Cockcroft-Gault Formula.
Oxygen saturation ≥ 90% on room air.
LVEF ≥ 40%.

You may not qualify if…

Prior allogeneic transplant (regardless of whether donor was related, unrelated, or cord). Prior autologous transplant is not exclusionary.
Presence of donor specific antibodies (DSA) with Mean Fluorescence Intensity (MFI) of ≥ 4000 as assessed by the single antigen bead assay.
Known HIV or active hepatitis B or C infection. Known current history of active tuberculosis.
Known hypersensitivity to one or more of the study agents.
Planning to receive antithymocyte globulin as part of the pre-transplant conditioning regimen.
Currently receiving or has received any investigational drugs within the 14 days prior to the first dose of study drug (Day -3).
Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of Day -3.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, autoimmune disease, symptomatic congestive heart failure, unstable angina pectoris, or unstable cardiac arrhythmias.
Immunosuppressive doses of steroids. Subjects with steroids for adrenal insufficiency will not be excluded.

Where it is running

Washington University School of Medicine — St Louis, Missouri, United States (enrolling)

Full record on ClinicalTrials.gov

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