IFN-γ to Treat Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) That Has Relapsed After Allogeneic Hematopoietic Stem Cell Transplantation

• Status: Recruiting
• Trial end date: 2022-01-31
• Target enrollment: 0
• Participant gender: All

Summary

This study proposes a safe dosing regimen IFN-γ that is sufficient to stimulate IFN-γ receptors on malignant blasts in patients who developed relapsed acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) after alloSCT with no active or history of III-IV acute graft-versus-host disease (GVHD). It is hypothesized that IFN-γ will promote graft-vs-leukemia (GVL) in patients with AML/MDS that has relapsed after alloSCT.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sawa Ito, MD; University of Pittsburgh
• Collaborator: Horizon Pharma USA, Inc.
• Treatments: Interferon-gamma; Interferons

Criteria

Inclusion Criteria:

• Recipients of allogeneic stem cell transplantation for acute myeloid leukemia or myelodysplastic syndrome from a human leukocyte antigen (HLA) matched donor

• Relapsed of primary disease with 5% to 20% of blasts in the bone marrow by flow cytometry in the bone marrow with an clear leukemia-associated immunophenotype (If the patient received therapy to treat the relapse, he or she must have 5-20% residual blasts prior to enrollment on this study)

• Performance status KPS score >60% (ECOG 0-2)

• No increases in systemic immunosuppression in the prior four weeks other than to maintain therapeutic levels

• No systemic corticosteroid with a dose higher than 0.5mg/kg/day prednisone or equivalent

• No history of grade IV acute GVHD

• No new systemic immunosuppressive medications in the prior two weeks initiated due to GVHD

• Willingness to have bone marrow and peripheral blood collected as per the study protocol

• Must be able to give informed consent

• Age 18 or older

Exclusion Criteria:

• Contraindication to receive IFN-γ including known hypersensitivity to interferon-gamma, E. coli derived products or any component of the product

• Subjects with a positive pregnancy test or who are breastfeeding

• For men or women of childing bearing potential (age < 50 without hysterectomy or oophorectomy or documented menopause), unwilling to use effective contraception for the duration of the study.

• Primary engraftment failure

• Active cardiac arrhythmias not controlled by medical management or current NYHA class II or higher congestive heart failure

• Active ischemic heart disease not well controlled with medications

• A seizure disorder not well controlled by medications

• Estimated GFR <30 mL/min

• AST/SGOT or ALT/SPOT > 5 x ULN

• Total bilirubin > 3 x ULN

• Chemotherapy (other than hypomethylating and/or venetoclax therapy) within the prior 4 weeks

• Body surface area at or less than 1.5 m2, or greater than 2.5 m2 so as to minimize the variation in IFN-γ exposure based on differences in BSA.

• Patients less than 18 years old.

• Pregnant or breastfeeding patients.