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Infusion of Alloreactive nk Cells for Mrd-positive Aml Patients

RecruitingNAAges 18 Years - anyAllIRCCS Azienda Ospedaliero-Universitaria di Bologna
NCT06885476 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This is a interventional, transplantation study. The procedure under study is the infusion of alloreactive NK cells in adult AML patients, eligible for ASCT, who achieved CR after conventional chemotherapy, but harbor MRD-positivity. Haploidentical KIR-L mismatched donors will be included if present at least one allele mismatch at a class I locus among the following ones: HLA-C alleles with Asn77-Lys80, HLA-C alleles with Ser77-Asn80, HLA-Bw4 alleles. KIR-L mismatched donor alloreactive NK cell repertoire will be evaluated in order to determine the functional cell dose to be used for NK cell collection. Phenotypical analysis of KIRs will be correlated to functional tests. NK cells will be selected from a steady-state large volume leukapheresis product from a suitable haploidentical KIR-ligand incompatible donor. NK cell purification will be performed if the donor leukapheresis product c

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📋 Eligibility rules (as published)
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).
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What it tests

  • Infusion of alloreactive NK cells
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Where

1 site
Antonio Curti
Bologna, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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