Infusion of specialized immune cells for patients with acute myeloid leukemia
Infusion of Alloreactive nk Cells for Acute Myeloid Leukemia Patients, Eligible for Allogeneic Stem Cell Transplantiation, With Persistent Minimal Residual Disease After Conventional Chemotherapy
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 22 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Drugs / interventions | chemotherapy, cyclophosphamide, fludarabine |
| Locations | 1 site (Bologna, BO) |
| Trial ID | NCT06885476 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Bologna, BO
- 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
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.