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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

ConditionsGraft Vs Host DiseaseGraft-versus-host-diseaseGraft Versus Host Disease
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorWashington University School of Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • Ruxolitinib

    Drug

    Ruxolitinib is provided by Incyte Corporation.

  • Abatacept

    Drug

    Abatacept is commercially available.

Treatment groups

41 Participants
are divided into 2 treatment groups
Group A: Regimen 1: RuxolitinibExperimental treatment 1 intervention
Group B: Regimen 2: Ruxolitinib + AbataceptExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Cumulative incidence of graft failure

Time frame
Day 35
2

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

Time frame
Day 100
3

Number of patients who experience CRS

Time frame
Through day 14

Secondary outcomes

1

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

Time frame
Day 100
2

Non-relapse mortality

Defined as death from any cause other than disease relapse.

Time frame
Day 180
3

Feasibility of regimen

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

Time frame
From day -3 to day 30

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Washington University School of Medicine

Lead sponsor

Incyte Corporation

Collaborator

Source ClinicalTrials.gov
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