Status:
RECRUITING
Infusion of Alloreactive nk Cells for Mrd-positive Aml Patients
Lead Sponsor:
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Conditions:
Acute Myeloid Leukemia
Minimal Residual Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 chemoth...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
January 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT06885476
Start Date
January 22 2021
End Date
December 1 2026
Last Update
March 20 2025
Active Locations (1)
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1
Antonio Curti
Bologna, BO, Italy, 40138