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Study identifier: NCT05686538 Synced from ClinicalTrials.gov · July 29, 2026
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Innate Donor Effector Allogeneic Lymphocyte Infusion After Stem Cell Transplantation: the IDEAL Trial

Condition: AML/MDS  ·  Sponsor: Rigshospitalet, Denmark

PhasePhase 2/Phase 3
Planned participants80
Who can joinAll sexes, 18 Years to 80 Years
Healthy volunteersNo

About this study

The curative principle behind allogeneic hematopoietic stem cell transplantation (HSCT) is eradication of the malignant cells of the patient (recipient) by donor graft cells, a process termed graft-versus-leukemia (GVL) effect. GVL is traditionally mediated by donor αβ T cells in an immunological process driven by genetical differences between individuals, i.e. an allogeneic response. For this reason, αβ T cells also cause an unwanted and dangerous complication of HSCT called graft-versus-host disease (GVHD) in which healthy recipient cells are targeted by donor cells with great risk of morbidity and mortality to the patient. In addition to αβ T cells, other cells from the donor stem cell graft, termed innate effector lymphocytes, can contribute to the GVL effect. These are termed natural killer (NK) cells and T-cell receptor (TCR) γδ cells, the latter being a subset of T cells. NK and TCR γδ cells can recognize and eliminate leukemic cells in a direct tumor response independent of conventional allogeneicity. Therefore, opposite αβ T cells, innate effector lymphocytes cells can mediate GVL but are not likely to cause GVHD. The main indications for HSCT in adults are acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). Approximately 50% of AML/MDS transplant patients experience significant acute GVHD and 30% experience relapse of the malignant disease. Prospective clinical studies from the research group of the investigators have shown that patients with high doses…

This description comes directly from the study's public registry record.

Talk to the study team

Lia Minculescu, MD, PhD  ·  +4535457958  ·  lia.minculescu@regionh.dk

Henrik Sengelov, Professor  ·  +4535458373  ·  henrik.sengeloev@regionh.dk

Always discuss trial participation with your own doctor first.

Locations (1)

Copenhagen University Hospital, RigshospitaletCopenhagen, DenmarkRecruiting

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Source record: clinicaltrials.gov/study/NCT05686538