This phase 2 study aims to confirm the efficacy seen in the prior phase 1 trial, and 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 test whether leukemia blasts were responsive to IFN-γ in vitro and in vivo, with single-cell RNA sequencing (scRNAseq) conducted to understand the transcriptomic changes induced by IFN-γ in leukemia cell subsets, including those with stem cell characteristics.
Age ≥ 18 years
Recipients of an alloSCT for AML or MDS from a minimally 8/8 HLA-matched donor
At least 5% or more myeloblasts based on bone marrow biopsy morphology by pathologist review. Abnormal myeloblasts cannot not exceed 30% overall 36
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.
Primary engraftment failure after alloSCT
Grade 3 or 4 aGVHD per Mount Sinai Acute GVHD International Consortium (MAGIC) at the time of planned enrollment
History of grade 4 aGVHD per the MAGIC criteria
Moderate or severe cGVHD per NIH Consensus Criteria at time of planned enrollment
Sawa Ito, MD
Lead sponsor
University of Pittsburgh
Sponsor institution
Evans MDS Discovery Research Grant
Collaborator
Amgen
Collaborator
FDA Office of Orphan Products Development
Collaborator