This phase I trial studies the side effects of interferon gamma-1b (IFN-gamma) in treating acute myeloid leukemia and myelodysplastic syndrome that has come back (relapsed) after donor blood transplant. Interferon-gamma is one of the proteins that T cells and other immune cells produce that play an important role in protecting the body from infections. This trial is being done to find out whether IFN-gamma can be safely given to patients with post-transplant relapse at a dose that can sufficiently stimulate the leukemia cells for immune-mediated killing and whether IFN-gamma can be given with a donor lymphocyte infusion, which is a standard therapy for patients who have relapsed post-transplant.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04628338.
PRIMARY OBJECTIVES:
I. To study whether the standard dose of interferon gamma-1b (IFN-gamma) is sufficient to upregulate human leukocyte antigen (HLA) I, HLA II, ICAM-1, and induce phosphorylated-STAT1 in malignant blasts in vivo in patients who have relapsed after allogeneic stem cell transplantation (alloSCT). (BIOLOGICAL)
II. To explore the feasibility and safety of administering IFN-gamma monotherapy post alloSCT and combined with donor lymphocyte infusion (DLI) in patients who have tolerated IFN-gamma monotherapy. (FEASIBILITY AND SAFETY)
SECONDARY OBJECTIVES:
I. Evaluate whether there is a reduction in malignant blast burden coincident with therapy.
II. Evaluate whether there is a progression of stable graft-versus-host disease (GVHD) or development of de novo GVHD coincident with therapy.
OUTLINE:
Patients receive interferon gamma-1b subcutaneously (SC) three times a week (TIW) in weeks 0-7 and once a week (QW) in weeks 8-12 in the absence of disease progression or unacceptable toxicity. Eligible patients undergo donor lymphocyte infusion at weeks 4, 8, and 12 in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 28 days and 6 months.
Lead OrganizationUniversity of Pittsburgh Cancer Institute (UPCI)
Principal InvestigatorSawa Ito
