Last updated 29 days ago

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

98 patients around the world
Available in Brazil
Hospital de Clinicas de Porto Alegre
1Research sites
98Patients around the world

This study is for people with

Leukemia
Acute myeloid leukemia

Requirements for the patient

To 75 Years
All Gender

Medical requirements

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.
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.

Sites

Hospital de Clínicas de Porto Alegre - HCPA/UFRGS
Rua Ramiro Barcelos, 2350, Av. Protásio Alves, 211 - Santa Cecília, Porto Alegre - RS, 90035-903
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