NCT04628338

IFN-γ to Treat Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) That Has Relapsed After Allogeneic Hematopoietic Stem Cell Transplantation

Completed EARLY_PHASE1 Last updated 29 April 2025

What this trial tests

EARLY_PHASE1 trial testing IFN-γ (interferon gamma-1b) injection in Myelodysplastic Syndromes in 8 participants. Completed in 30 October 2023.

Timeline

8 March 2021

Primary endpoint
30 October 2023

30 October 2023

Quick facts

Lead sponsor	Sawa Ito, MD
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	8
Start date	8 March 2021
Primary completion	30 October 2023
Estimated completion	30 October 2023
Sites	1 location across United States

Drugs / interventions tested

• IFN-γ (interferon gamma-1b) injection — full drug profile →

Conditions studied

• Myelodysplastic Syndromes — all drugs for Myelodysplastic Syndromes →
• Myeloid Leukemia — all drugs for Myeloid Leukemia →
• Allogeneic Stem Cell Transplantation — all drugs for Allogeneic Stem Cell Transplantation →

Sponsor

Sawa Ito, MD — full company profile →

Who can join

18 and older, any sex, with Myelodysplastic Syndromes or Myeloid Leukemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Relapse of acute myeloid leukemia after allogeneic stem cell transplantation: immune escape mechanisms and current implications for therapy.
   Sauerer T, Velázquez GF, Schmid C. · · 2023 · cited 67× · PMID 37951964 · DOI 10.1186/s12943-023-01889-6
2. Inflammation in cancer: therapeutic opportunities from new insights.
   Xie Y, Liu F, Wu Y, Zhu Y, et al · · 2025 · cited 53× · PMID 39994787 · DOI 10.1186/s12943-025-02243-8
3. The cytokine network in acute myeloid leukemia.
   Luciano M, Krenn PW, Horejs-Hoeck J. · · 2022 · cited 52× · PMID 36248849 · DOI 10.3389/fimmu.2022.1000996
4. Flotetuzumab and other T-cell immunotherapies upregulate MHC class II expression on acute myeloid leukemia cells.
   Rimando JC, Chendamarai E, Rettig MP, Jayasinghe R, et al · · 2023 · cited 27× · PMID 36563336 · DOI 10.1182/blood.2022017795
5. LILRB3 Modulates Acute Myeloid Leukemia Progression and Acts as an Effective Target for CAR T-cell Therapy.
   Mai S, Hodges A, Chen HM, Zhang J, et al · · 2023 · cited 15× · PMID 38098451 · DOI 10.1158/0008-5472.can-22-2483
6. Myeloid activation clears ascites and reveals IL27-dependent regression of metastatic ovarian cancer.
   Murphy B, Miyamoto T, Manning BS, Mirji G, et al · · 2024 · cited 8× · PMID 39570374 · DOI 10.1084/jem.20231967
7. The Immune Resistance Signature of Acute Myeloid Leukemia and Current Immunotherapy Strategies.
   Chandra DJ, Alber B, Saultz JN. · · 2024 · cited 7× · PMID 39123343 · DOI 10.3390/cancers16152615
8. Biglycan as a mediator of proinflammatory response and target for MDS and sAML therapy.
   Vaxevanis CK, Bauer M, Subbarayan K, Friedrich M, et al · · 2023 · cited 6× · PMID 36531688 · DOI 10.1080/2162402x.2022.2152998