New drug combo aims to tame stem cell transplant complications
NCT ID NCT06008808
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial tests whether two drugs, ruxolitinib and abatacept, can prevent graft-versus-host disease (GVHD) and cytokine release syndrome in people receiving stem cell transplants from half-matched donors. About 41 adults with blood cancers will take these drugs around the time of transplant. The goal is to reduce dangerous immune reactions while preserving the transplant's ability to fight cancer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Ruxolitinib and abatacept
- What this could lead to
- If successful, this could lead to a safer way to prevent graft-versus-host disease after half-matched stem cell transplants, making this life-saving treatment available to more patients.
- What could go wrong
- This is a very early Phase 1 trial with only 41 participants, so results may not apply broadly. The drugs may not reduce GVHD as hoped, and side effects like infection or graft failure remain possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 41 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2024
- Expected to finish
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Nov 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 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%. * FEV1 and FVC ≥ 40% predicted, DLCOc ≥ 40% predicted. If DLCO is \< 40%, patients will still be considered eligible if deemed safe after a pulmonary evaluation. * Able to receive GVHD prophylaxis with tacrolimus, mycophenolate mofetil (if applicable), and cyclophosphamide. * At least 18 years of age at the time of study consent * The effects of ruxolitinib and abatacept on the developing human fetus are unknown. Additionally, tacrolimus may increase risk of hypertension, preeclampsia, preterm birth, and low birth weight; and mycophenolate mofetil is considered to be teratogenic. For this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study and for the duration of the study. * Able to understand and willing to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable). Exclusion Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Washington University School of Medicine
RECRUITINGSt Louis, Missouri, 63110, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Platelet-Boosting drug help control a rare bone marrow disorder?
- Stem cell infusions put to the test against a tough transplant complication
- Double-Drug attack on Hard-to-Treat lymphomas
- PET scans guide Nivolumab-Chemo combo in relapsed hodgkin lymphoma
- Patient's own t cells engineered to hunt lymphoma in early trial
- Tweaking donor cells may shield older transplant patients from a dangerous complication