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
This study tests whether a combination of two drugs called ruxolitinib and abatacept can prevent serious side effects that sometimes occur after a blood stem cell transplant from a partially matched family member. These side effects, called graft-versus-host disease and cytokine release syndrome, happen when the donor cells attack the patient's body or cause dangerous inflammation.
Key Objective:The trial is testing whether adding abatacept to ruxolitinib can better prevent graft-versus-host disease and cytokine release syndrome after haploidentical stem cell transplantation.
Who to Consider:Patients with blood cancers who need a stem cell transplant and have a partially matched family member donor should consider enrolling.
Trial Parameters
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Brief 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 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
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 periphe