]>
IRCT20230801058996N3 IRCT 2023-10-07 Shahid Beheshti University of Medical Sciences Activated NK cell therapy to negate MRD in AML patients Safety and efficacy of cell therapy with allogeneic natural killer cells activated with interleukin 2 and 15 in patients with refractory non-M3 acute myeloid leukemia (absence of hematological, morphological or molecular response after at least two treatment regimens) 2023-09-22 anticipated 15 Complete https://irct.ir/trial/72440 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 1-2 Acute myeloid leukemia. Intervention group: patients with acute myeloid leukemia (other than M3) undergo cell therapy with allogeneic natural killer cells activated with interleukin 2 and 15. First, the allogeneic donor is undergo apheresis to isolate mononuclear cells. Then the NK cells are enriched from the apheresis product using the CliniMacs device. These cells are incubated overnight with interleukin 2 and 15 to activate. Activated cells are injected into patients in three incremental doses of one, three, and five million cells per kilogram of body weight, respectively.. 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(non-M3) diagnosed according to the World Health Organization classification Inadequate response to induction therapy (incomplete or complete remission with minimal positive residual disease) Relapse (Hematologic, morphologic or positive minimal residual disease) Karnofsky index above 70% 12 years 80 years Both Patients with acute myeloid leukemia-M3 Patients with low-risk acute myeloid leukemia Patients in complete molecular remission C92.0 Acute myeloblastic leukemia Treatment - Other Intervention group: patients with acute myeloid leukemia (other than M3) undergo cell therapy with allogeneic natural killer cells activated with interleukin 2 and 15. First, the allogeneic donor is undergo apheresis to isolate mononuclear cells. Then the NK cells are enriched from the apheresis product using the CliniMacs device. These cells are incubated overnight with interleukin 2 and 15 to activate. Activated cells are injected into patients in three incremental doses of one, three, and five million cells per kilogram of body weight, respectively. The percentage of 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. Response to treatment (Based on hematologic, morphologic and molecular assessments). 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. 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. Shahid Beheshti University of Medical Sciences Javidan Motaher Charity Foundation of Tehran Pharmed Behin Azma Approved 2023-07-01 Ethics committee of Shahid Beheshti University of medical Sciences Taleghani Hospital, Aarabi street, Yaman street, Chamran highway Tehran Tehran Iran (Islamic Republic of)