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AzTrials

Graft Vs Host DiseasePhase 1NCT06008808

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

A Phase 1 study testing Ruxolitinib and Abatacept in people with Graft Vs Host Disease and Graft-versus-host-disease, run by Washington University School of Medicine at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Ruxolitinib and Abatacept
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
1 siteUnited States
Study dates
7 May 2024to 27 Nov 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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).

Who cannot join

  • 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).
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ramzi Abboud, M.D. contact

314-454-8304

rabboud@wustl.edu

United States1 site, 1 recruiting

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    Ramzi Abboud, M.D., 314-454-8304, rabboud@wustl.edu

    Ramzi Abboud, M.D.

    Recruiting

Other trials in United States

About this study

Official title: An Open-Label Phase I Study of JAK Inhibitor 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

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.

Being tested
Ruxolitinib, Abatacept
Keywords
Haploidentical, GVHD, CRS
Medical subject headings
Graft vs Host Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RuxolitinibDrug

    Also called Jakafi

    Ruxolitinib is provided by Incyte Corporation.

  • AbataceptDrug

    Abatacept is commercially available.

Study groups in NCT06008808
Study groupRoleWhat they receive
Regimen 1: RuxolitinibExperimental-Ruxolitinib at 5 mg twice per day (BID) beginning on Day -3 and continuing until Day 180 followed by a taper (duration of taper depends on dose of ruxolitinib at Day 180). Once a patient's counts have reached ANC ≥ 1.5 K/cumm, hemoglobin ≥ 9.0 g/dL, and platelets ≥ 50 K/cumm, ruxolitinib dosing will escalate to 10 mg BID.
Receives: Drug: Ruxolitinib
Regimen 2: Ruxolitinib + AbataceptExperimental* Ruxolitinib at 5 mg twice per day (BID) beginning on Day -3 and continuing until Day 180 followed by a taper (duration of taper depends on dose of ruxolitinib at Day 180). Once a patient's counts have reached ANC ≥ 1.5 K/cumm, hemoglobin ≥ 9.0 g/dL, and platelets ≥ 50 K/cumm, ruxolitinib dosing will escalate to 10 mg BID. * In addition, patients will receive abatacept 10 mg/kg IV over 30 minutes on days +5, +14, +28, and +56.
Receives: Drug: Ruxolitinib; Drug: Abatacept

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cumulative incidence of graft failure

    Measured: Day 35

  2. Cumulative incidence of grades III-IV acute GVHD by MAGIC criteria

    Measured: Day 100

  3. Number of patients who experience CRS

    Measured: Through day 14

Secondary outcomes (3)

  1. Cumulative incidence of grades II-IV acute GVHD by MAGIC criteria

    Measured: Day 100

  2. Non-relapse mortality

    Defined as death from any cause other than disease relapse.

    Measured: Day 180

  3. Feasibility of regimen

    Defined as at least 80% of patients successfully taking at least 80% of the ruxolitinib dose

    Measured: From day -3 to day 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2023
  2. Study start7 May 2024
  3. Primary completion8 Sep 2027 (estimated)
  4. Study completion27 Nov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
41 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06008808
Sponsor's protocol ID
202401211
Status last verified
Apr 2026
First submitted
18 Aug 2023
Last updated
22 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ruxolitinib and Abatacept in people with Graft Vs Host Disease and Graft-versus-host-disease, run by Washington University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 30 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ramzi Abboud, M.D. (314-454-8304, rabboud@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cumulative incidence of graft failure (time frame: Day 35). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06008808.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.

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