Infusion of donor lymphocytes after stem cell transplantation for AML/MDS
Official title: Innate Donor Effector Allogeneic Lymphocyte Infusion After Stem Cell Transplantation: The IDEAL Trial
Run by Copenhagen University Hospital, Rigshospitalet · NCT05686538 · Data updated 2026-11-12
This study is testing whether adding donor lymphocyte infusions after stem cell transplants can help improve outcomes for adults with acute myeloid leukemia or myelodysplastic syndromes.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Copenhagen University Hospital, Rigshospitalet Academic / other |
| Locations | 1 site (Copenhagen) |
| Status | Recruiting |
| Started | January 1, 2022 |
| Main results expected | January 2028 |
| Study ends | January 2030 |
| Registry record updated | April 10, 2024 |
| Trial ID | NCT05686538 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 and older diagnosed with AML or MDS who are undergoing allogeneic HSCT.
✕Probably not a fit
Patients who may not benefit from this study include those requiring central venous access for the leukapheresis procedure or those with other significant comorbidities.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effects of adding innate donor lymphocyte infusion (iDLI) to the treatment of patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) who have undergone allogeneic hematopoietic stem cell transplantation (HSCT). The study aims to improve transplant outcomes by evaluating the impact of iDLI on acute graft-versus-host disease (GVHD), relapse rates, and overall survival. Participants will receive iDLI early after transplantation to enhance the graft-versus-leukemia (GVL) effect while minimizing the risk of GVHD. The trial includes patients aged 18 and older who meet specific eligibility criteria.
Why it matters
Potential benefit: If successful, this approach could lead to improved survival rates and reduced relapse in patients undergoing stem cell transplantation for AML/MDS.
How similar studies have gone: While the use of donor lymphocyte infusion is established, this specific approach focusing on innate lymphocytes is novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnoses: AML, MDS * Age: ≥18 years * Graft type: PBSC * Donor: ≥18 years * Informed consent from both donor and recipient Exclusion Criteria: • Donors with need for central venous access for the leukapheresis procedure
Where it's running
-
Copenhagen University Hospital, Rigshospitalet
Copenhagen, Denmark Recruiting
Study contacts
- Study coordinator: Lia Minculescu, MD, PhD
- Email: lia.minculescu@regionh.dk
- Phone: +4535457958
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.