Interferon-γ (IFN-γ) With Donor Leukocyte Infusion to Treat Relapsed Acute Myeloid Leukemia and Myelodysplastic Syndromes Post Allogeneic Hematopoietic Stem Cell Transplantation

Inclusion Criteria

• •1. Age ≥ 18 years
• •2. Recipients of an alloSCT for AML or MDS from a minimally 8/8 HLA-matched donor
• •3. AML/MDS relapsed post-alloSCT with measurable residual disease defined by either of the following criteria:
• •1. At least 5% or more myeloblasts based on bone marrow biopsy morphology by pathologist review. Abnormal myeloblasts cannot not exceed 30% overall 36
• •2. At least 0.1% of abnormal myeloblasts with a leukemia-associated immunophenotype (LAIP) by multiparameter flow cytometry. The abnormal cells with LAIP should not exceed 30% of nucleated cells.
• •3. Recurrent or persistent cytogenetic abnormalities detectable by FISH or karyotype analysis.
• •4. For patients with mutant NPM1, at least 1,000 mutant transcript copies per 106 ABL or equivalent housekeeping transcripts in bone marrow by qPCR or dPCR
• •4. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2
• •5. A DLI is available, or the donor is available and agrees to undergo apheresis to collect lymphocytes for infusion
• •6. If salvage therapy for post-alloSCT relapse was received, the therapy is limited to 1 line of the following:
• •1. For hypomethylating agents, venetoclax, and targeted therapies (e.g., tyrosine kinase inhibitors, IDH1/IDH2 inhibitors, or FLT3 inhibitors), the last dose must be \> 2 week prior to the initiation of IFN-γ
• •2. For cytotoxic chemotherapy agents, the last dose must be \>2 weeks prior to start of treatment for the present study
• •3. For investigational agents, the last dose must be ≥ 4 weeks or 5 half-lives (whichever is longer) prior to the start of treatment for the present study
• •7. Provision of signed and dated informed consent form
• •8. Stated willingness to comply with all study procedures and availability for the duration of the study
• •9. For female subject, who is \< 55 years old without hysterectomy, oophorectomy or documented menopause, willingness to use two forms of contraception including one form of highly effective contraception (i.e., long-acting reversible contraception, oral contraceptive pills) for the duration of the study
• •10. For male subject, willingness to use highly effective contraception methods including male condoms by male subject and one form of highly effective contraception by his female partner (i.e., long-acting reversible contraception, oral contraceptive pills) for the duration of the study