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Search / Trial NCT06885476

Infusion of Alloreactive nk Cells for Mrd-positive Aml Patients

Launched by IRCCS AZIENDA OSPEDALIERO-UNIVERSITARIA DI BOLOGNA · Mar 18, 2025

Trial Information

Current as of April 22, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment for adults with Acute Myeloid Leukemia (AML) who have achieved a state of remission but still have some cancer cells present, known as minimal residual disease (MRD). The researchers want to see if infusing special immune cells called alloreactive natural killer (NK) cells, which come from a closely matched donor, can help these patients. To participate, patients must be at least 18 years old, have a specific type of AML, and have a compatible donor available. They also need to be well enough to undergo the treatment and meet certain health criteria.

Participants in this trial can expect to receive a combination of chemotherapy to prepare their bodies for the NK cell infusion. After the infusion, they will receive additional treatment to help the NK cells work effectively. Throughout the trial, patients will have regular check-ups and tests to monitor their health and to study how well the NK cells are performing. The entire process is designed to last at least 12 months, during which researchers will gather important information to better understand the effectiveness of this treatment for AML patients.

Gender

ALL

Eligibility 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).

Trial Officials

Antonio Curti

Principal Investigator

Istituto di Ematologia Seràgnoli, Azienda Ospedaliero-Universitaria di Bologna (IRCCS)

About Irccs Azienda Ospedaliero Universitaria Di Bologna

IRCCS Azienda Ospedaliero-Universitaria di Bologna is a prestigious research and healthcare institution in Italy, renowned for its commitment to advancing medical science and patient care through innovative clinical research. As an IRCCS (Istituto di Ricovero e Cura a Carattere Scientifico), it integrates clinical practice with scientific research, facilitating the translation of laboratory findings into effective treatment strategies. The institution fosters a multidisciplinary approach, collaborating with various experts to conduct high-quality clinical trials aimed at improving health outcomes across a wide range of medical fields. With a strong emphasis on ethical standards and patient welfare, IRCCS Azienda Ospedaliero-Universitaria di Bologna plays a vital role in shaping the future of medicine through rigorous scientific inquiry and patient-centered care.

Locations

Bologna, Bo, Italy

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported