Infusion of donor lymphocytes after stem cell transplantation for AML/MDS
Innate Donor Effector Allogeneic Lymphocyte Infusion After Stem Cell Transplantation: The IDEAL Trial
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 |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Locations | 1 site (Copenhagen) |
| Trial ID | NCT05686538 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with AML or MDS who are undergoing allogeneic HSCT.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Copenhagen
- Copenhagen University Hospital, Rigshospitalet — Copenhagen, Denmark (Recruiting)
Study contacts
- Study coordinator: Lia Minculescu, MD, PhD
- Email: lia.minculescu@regionh.dk
- Phone: +4535457958
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.