Clinical trial · Interventional
IFN-γ to Treat Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) That Has Relapsed After Allogeneic Hematopoietic Stem Cell Transplantation
A Pilot Study of IFN-γ to Treat Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) That Has Relapsed After Allogeneic Hematopoietic Stem Cell Transplantation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Allogeneic Stem Cell Transplantation | — | UNRESOLVED | — |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
| Myeloid Leukemia | Myeloid Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IFN-γ (interferon gamma-1b) injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IFN-γ
- description
- 100mcg IFN-γ subcutaneously three times per week (Weeks 0-7), once per week (Weeks 8-12) (or per protocol guidance based on tolerability, response, or DLI infusions)
- interventionNames
- Drug: IFN-γ (interferon gamma-1b) injection
Primary outcomes (5)
- measure
- Upregulation HLA l (HLA-ABC)
- timeFrame
- Up to 6 months
- description
- Upregulation of HLA l (HLA-ABC) in bone marrow malignant blasts post-IFN-γ treatment, measured by the change in mean florescent intensity by flow cytometry.
- measure
- Upregulation of HLA ll (HLA-DR/DQ)
- timeFrame
- Up to 6 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- BACKGROUNDIto S, Geramita E, Ventura K, Neupane B, Bhise S, Moore EM, Furlan S, Shlomchik WD. IFN-gamma and donor leukocyte infusions for relapsed myeloblastic malignancies after allogeneic hematopoietic stem cell transplantation. JCI Insight. 2025 Mar 25;10(9):e190655. doi: 10.1172/jci.insight.190655. eCollection 2025 May 8. PMID 40131369