Infusion of specialized immune cells for patients with acute myeloid leukemia
Official title: Infusion of Alloreactive nk Cells for Acute Myeloid Leukemia Patients, Eligible for Allogeneic Stem Cell Transplantiation, With Persistent Minimal Residual Disease After Conventional Chemotherapy
Run by IRCCS Azienda Ospedaliero-Universitaria di Bologna · NCT06885476 · Data updated 2026-11-12
This study is testing whether infusing special immune cells from a matched donor can help adults with acute myeloid leukemia who are in remission but still have some remaining cancer cells.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 22 (estimated) |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Drugs / interventions | chemotherapy, cyclophosphamide, fludarabine |
| Locations | 1 site (Bologna, BO) |
| Status | Recruiting |
| Started | January 22, 2021 |
| Main results expected | December 2025 |
| Study ends | December 2026 |
| Registry record updated | March 20, 2025 |
| Trial ID | NCT06885476 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with de novo or secondary AML who have achieved complete remission but are MRD-positive and have a suitable haploidentical donor.
✕Probably not a fit
Patients with acute myeloid leukemia FAB M3, those with uncontrolled infections, or individuals who are pregnant or nursing may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study focuses on the infusion of alloreactive natural killer (NK) cells in adult patients with acute myeloid leukemia (AML) who have achieved complete remission but still show minimal residual disease (MRD). Eligible participants must have a haploidentical donor with specific genetic mismatches. The study aims to evaluate the functional capacity of NK cells collected from these donors and their potential effectiveness in treating MRD-positive AML. The methodology includes immunomagnetic enrichment of NK cells to ensure a sufficient dose for infusion.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes for AML patients by effectively targeting residual cancer cells.
How similar studies have gone: While the use of NK cell infusions is a promising area of research, the specific approach of using haploidentical KIR-L mismatched donors is relatively novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of de novo or secondary AML * Age ≥ 18 years * Morphologic CR * Eligibility for ASCT * MRD-positivity after induction chemotherapy * Availability of a KIR-L incompatible haploidentical donor * Performance Status ≥ 70% (Karnofsky score) or ≤ 2 (WHO). * Adequate renal (serum creatinine \< 2 mg/dl), pulmonary (Sat O2 ≥ 96%) and hepatic (ALT/AST \< 2.5 x N) function. * Left Ventricular Ejection Fraction (LVEF) of \>50% as determined by Echocardiogram (ECHO). * Signed informed consent. Exclusion Criteria: * Diagnosis of AML FAB M3 * HIV positivity. * HCV positivity with high viral load. * Pregnant or nursing females. * Current uncontrolled infection. * Signs or symptoms of fluid retention (e.g. pleural effusion).
Where it's running
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Antonio Curti
Bologna, Bo, Italy Recruiting
Study contacts
- Principal investigator: Antonio Curti — Istituto di Ematologia Seràgnoli, Azienda Ospedaliero-Universitaria di Bologna (IRCCS)
- Study coordinator: Antonio Curti
- Email: antonio.curti2@unibo.it
- Phone: +390512144074
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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.