NK Cell Infusion for Remission Consolidation in AML: A Phase II Trial

Launched by HOSPITAL DE CLINICAS DE PORTO ALEGRE · Jan 14, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for adults with Acute Myeloid Leukemia (AML) who are in complete remission after standard chemotherapy. The goal is to see if using special immune cells called natural killer (NK) cells, taken from healthy donors, can help prevent the cancer from coming back. In this study, participants will receive either NK cell infusions or a placebo (a non-active treatment) after their chemotherapy. The trial aims to find out if the NK cells can improve survival and reduce any remaining cancer cells in the body.

To be eligible for this trial, participants need to be between 18 and 75 years old, have a confirmed diagnosis of AML (but not a specific type called acute promyelocytic leukemia), and be in complete remission after receiving initial treatment. They also need to have a suitable donor for the NK cells. Throughout the trial, participants will receive six infusions and will be closely monitored for their immune response and overall health. Importantly, the trial is not yet recruiting participants, so interested individuals will need to wait until it officially starts.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male or female patients aged 18 to 59 years, and 60 to 75 years if their score is \< 0.4 on the 10-minute Comprehensive Geriatric Assessment (CGA-10);
• • Recently diagnosed acute myeloid leukemia, excluding acute promyelocytic leukemia confirmed by the molecular finding of PML-RARA or the presence of t(15:17) in genetic evaluation;
• • In first complete hematologic remission after remission induction;
• • Eligible, in the opinion of the principal investigator, to undergo consolidation chemotherapy with HDAra-C;
• • No history of NYHA \> III heart failure, acute myocardial infarction, or unstable angina in the past 6 months;
• • Negative beta-HCG test for women of childbearing potential and agreement to use contraceptive methods throughout the treatment, from the time of informed consent signature until one month after the last dose of treatment;
• • Non-reactive HIV serology;
• • No prior investigational therapy in the 4 weeks before study enrollment;
• • Availability of a haploidentical peripheral blood donor;
• • Signed informed consent form.
• Exclusion Criteria:
• • Patients under 18 years of age; or aged 60 to 75 years with a score \> 0.4 on the CGA-10 scale; or over 76 years of age, regardless of the score on the CGA-10 scale.
• • Diagnosis of acute promyelocytic leukemia confirmed by the molecular finding of PML-RARA or the presence of t(15:17) in genetic evaluation.
• • Failure to achieve first complete hematologic remission after remission induction.
• • Ineligible, in the investigator's opinion, to undergo consolidation chemotherapy with HDAra-C.
• • History of NYHA \> III heart failure, acute myocardial infarction, or unstable angina in the past 6 months.
• • Positive beta-HCG test for women of childbearing potential or non-compliance with using contraceptive methods throughout the treatment, from the time of informed consent signature until one month after the last dose of treatment.
• • Reactive HIV serology.
• • Prior investigational therapy in the four weeks preceding study enrollment.
• • Lack of availability of a haploidentical peripheral blood donor.
• • Failure to sign the informed consent form.