Clinical trial Recruiting at 1 site Phase2; Phase3 Interventional Ages 18 to 80

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.

More AML/MDS trials

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Ages18 Years to 80 Years
SexAll
Enrollment80 (estimated)
SponsorCopenhagen University Hospital, Rigshospitalet
Academic / other
Locations1 site (Copenhagen)
StatusRecruiting
StartedJanuary 1, 2022
Main results expectedJanuary 2028
Study endsJanuary 2030
Registry record updatedApril 10, 2024
Trial IDNCT05686538 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.