A Prospective, Multicenter Clinical Trial of the Interleukin-1 Receptor Antagonist Anakinra for the Prevention of Poor Graft Function Following Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Myelodysplastic Syndromes
Sponsor study identifier
interventional
66
1 country
1
Study Start
October 5, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
November 15, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 15, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Preclinical evidence indicates that IL-1 inflammatory signaling suppresses bone marrow mesenchymal stromal cells (MSCs) from secreting stem cell factor (SCF), leading to failure of their hematopoietic supportive capacity, and that the interleukin-1 receptor antagonist (IL-1Ra, Anakinra) can reverse this process. Sustained low-level IL-1 signaling also drives hematopoietic stem cell (HSC) dysfunction, including progression of clonal hematopoiesis and transformation to myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML). A prior phase 2 trial of IL-1 inhibition in lower-risk MDS demonstrated hematologic improvement without an increased risk of leukemic transformation. Based on these findings, this study hypothesizes that early administration of Anakinra after allogeneic hematopoietic stem cell transplantation (allo-HSCT) in patients with MDS, by inhibiting IL-1β signaling, improving the bone marrow microenvironment, and reducing the occurrence of poor graft function (PGF), does not increase the risk of post-transplant relapse. The study comprises two parts: a dose-escalation phase to determine the maximum tolerated dose (MTD) / recommended phase 2 dose (RP2D) of Anakinra in post-allo-HSCT patients, and an efficacy-validation phase to evaluate the preventive effect of Anakinra at the RP2D on PGF.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 15, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 5, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 15, 2026
Actual (reported)October 22, 2026
Actual (reported)November 15, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
November 15, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
incidence of poor graft function (PGF) by Day +100
Persistent ≥2 lineage cytopenias, donor chimerism ≥95%
100 days post-HCT
Overall survival
2 year post-HCT
Non-relapse mortality
2 year post-HCT
Relapse
2 year post-HCT
Incidence of acute GVHD
180 days post-HCT
Part 1. Anakinra SC thrice weekly Day 0→+28; dose levels 100/200/300 mg assigned via standard 3+3 escalation to determine MTD and RP2D; Part 2. Anakinra at the RP2D (from Part 1) SC thrice weekly Day 0→+28, to evaluate prevention of poor graft function.
Recombinant interleukin-1 receptor antagonist. Subcutaneous, thrice weekly from Day 0 through Day +28 after allo-HSCT.
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Ruijin Hospital
Shanghai, 200025, China
First Submitted
October 15, 2026
First Posted
October 22, 2026
Study Start
October 5, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
November 15, 2027
EstimatedPilot Study of the Safety and Efficacy of Anakinra (Recombinant Human Interleukin-1 Receptor Antagonist) in Heart Failure
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Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 15, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 22, 2026
Record last verified: 2026-09
De-identified individual participant data will be shared upon reasonable request to the principal investigator after publication of the main results.
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Source: ClinicalTrials.gov.
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