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IRCT20230801058996N2 IRCT 2023-09-10 Shahid Beheshti University of Medical Sciences Natural killer cell therapy in acute myeloid leukemia patients patients Safety and efficacy of allogeneic natural killer cells therapy in acute myeloid leukemia (other than M3) patients transplanted with allogeneic hematopoietic stem cell 2023-08-22 anticipated 15 Complete https://irct.ir/trial/72368 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 1-2 Acute myeloid leukemia. Intervention group: Allogeneic natural killer cell therapy. No - There is not a plan to make this available Justification or reason for not sharing IPD is Due to the confidentiality of patient information
public Elham Roshandel
Taleghani Hospital, Aarabi street, Yaman street, Chamran highway
Tehran Iran (Islamic Republic of) ۱۹۸۵۷۱۱۱۵۱ +98 21 2303 1658 elham.roshandel@gmail.com Shahid Beheshti University of Medical Sciences scientific Elham Roshandel
Taleghani Hospital, Aarabi street, Yaman street, Chamran highway
Tehran Iran (Islamic Republic of) ۱۹۸۵۷۱۱۱۵۱ +98 21 2303 1658 elham.roshandel@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients with acute myeloid leukemia (other than M3) confirmed by peripheral blood and bone marrow morphology, and flow cytometry and molecular assessments History of transplantation with compatible allogeneic hematopoietic stem cells Kanofsky index above 70% Expected survival of more than six months Absence of other confirmed malignancies Entering the second complete remission phase (recovery of patients after the first recurrence) High risk-patients with negative or positive minimal residual disease 12 years 80 years Both Patients with acute myeloid leukemia-M3 Central nervous system involvement with leukemic cells in the last 3 months C92.0 Acute myeloblastic leukaemia Treatment - Other Intervention group: Allogeneic natural killer cell therapy The percentage of patients who show adverse effects during or after NK cell therapy. Timepoint: From the first dose of NK cells infusion until six months after its last dose. Method of measurement: The patient's statements and the medical team's examinations during the patient's regular visits to the bone marrow transplantation clinic for follow-up. Overall survival in patients after NK cell therapy. Timepoint: From the first dose of NK cells infusion until six months after its last dose. Method of measurement: Regular patient visits to bone marrow transplantation clinic for follow-up and regular telephone monitoring of patients. Response to treatment based on criteria defined by the International Multiple Myeloma Working Group. Timepoint: From the first dose of NK cells infusion until six months after its last dose. Method of measurement: Regular patient examination in bone marrow transplantation clinic for follow-up and based on criteria defined by the International Multiple Myeloma Working Group. Evaluation of "Event Free Survival" in a six month period. Timepoint: From the first dose of NK cells infusion until six months after its last dose. Method of measurement: Regular patient visits to bone marrow transplantation clinic for follow-up and regular telephone monitoring of patients. Evaluation of "Progression free survival" in a six month period. Timepoint: From the first dose of NK cells infusion until six months after its last dose. Method of measurement: Regular patient visits to bone marrow transplantation clinic for follow-up and regular telephone monitoring of patients. Evaluation of "non-relapse mortality" in a six month period. Timepoint: From the first dose of NK cells infusion until six months after its last dose. Method of measurement: Regular patient visits to bone marrow transplantation clinic for follow-up and regular telephone monitoring of patients. Evaluation of "Overall survival" in a six month period. Timepoint: From the first dose of NK cells infusion until six months after its last dose. Method of measurement: Regular patient visits to bone marrow transplantation clinic for follow-up and regular telephone monitoring of patients. Evaluation of "graft versus host disease" in a six month period. Timepoint: From the first dose of NK cells infusion until six months after its last dose. Method of measurement: Regular patient visits to bone marrow transplantation clinic for follow-up and regular telephone monitoring of patients. Shahid Beheshti University of Medical Sciences Javidan Motaher Charity Foundation of Tehran Pharmed Behin Azma Approved 2023-08-12 Ethics committee of Shahid Beheshti University of medical Sciences Taleghani Hospital, Aarabi street, Yaman street, Chamran highway Tehran Tehran Iran (Islamic Republic of)