Interferon-γ (IFN-γ) With Donor Leukocyte Infusion to Treat Relapsed Acute Myeloid Leukemia and Myelodysplastic Syndromes Post Allogeneic Hematopoietic Stem Cell Transplantation
Eligible age
18+ yrs
Accepts
All genders
Locations
3 states
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
This phase 2 study aims to confirm the efficacy observed in the prior phase 1 trial in Cohort 1 and to evaluate the safety of IFN-γ in combination with DLI in Cohort 2, the haploidentical donor alloSCT recipient cohort. The study will further contribute to this effort through the collection of leukemia cells pre- and post-in vivo IFN-γ therapy. As in the previously conducted phase 1 trial, this trial will assess whether leukemia blasts are responsive to IFN-γ in vitro and in vivo. Single-cell RNA sequencing (scRNAseq) will be performed to evaluate transcriptomic changes induced by IFN-γ in leukemia cell subsets, including those with stem cell characteristics.
Sponsor: Sawa Ito, MD
You may qualify if…
- ✓ 1. Age ≥ 18 years
- ✓ 2. Recipients of an alloSCT for AML or MDS from a minimally 8/8 HLA-matched donor (Cohort 1: HLA -matched alloSCT recipients) or recipients of a haploidentical donor SCT for AML or MDS from a minimally 4/8 HLA-matched donor (Cohort 2: Haplo-SCT recipients)
- ✓ 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
You may not qualify if…
- ✕ 1. Primary engraftment failure after alloSCT
- ✕ 2. Evidence of mixed phenotype leukemia with lymphoid differentiation (Cohort 1: HLA -matched alloSCT recipients)
- ✕ 3. Grade 3 or 4 aGVHD per Mount Sinai Acute GVHD International Consortium (MAGIC) at the time of planned enrollment
- ✕ 4. History of grade 4 aGVHD per the MAGIC criteria
- ✕ 5. Moderate or severe cGVHD per NIH Consensus Criteria at time of planned enrollment
- ✕ 6. Any systemic immunosuppressive medications taken within 2 weeks before the enrollment
- ✕ 7. Grade 3 or higher non-hematologic toxicity related to any prior therapy at the time of enrollment
- ✕ 8. A contraindication to receive IFN-γ including a known hypersensitivity to IFN-γ, E. coli derived products or any other component of the product
Where it's recruiting
Source: ClinicalTrials.gov · NCT06529731 · last updated 2026-08-11