]>
IRCT20200417047113N2 IRCT 2023-01-25 Middle East Gene Therapy corporation Effect of treatmen with natural killer cells in acute myeloid leukemia Evaluation of efficacy and safety of allogeneic activated Natural Killer cells in adult patients with relapsed/refractory acute myeloid leukemia. 2022-12-22 anticipated 5 Complete https://irct.ir/trial/66736 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 2 Acute Myeloid leukemia. Intervention group: The preparation and injection of the first round of natural killer cells (NK) is done as soon as entering the study. Injections are done in three times, once a week. Before receiving NK cells, fludarabine and cyclophosphamide drugs are prescribed. NK suspended in 63 ml of 6% albumin solution is injected intravenously (central vein) for 16-23 minutes. In each NK injection, the number of injected live cells is determined based on the patient's weight. The injected NK cell is considered to be at least 10 to the power of 6 cells per kilogram of body weight. The number of injected cells is calculated based on the number of living cells.. Yes - There is a plan to make this available What will be shared: After de-identifying individuals, a portion of the data that contain information related to the main outcome could be shared When: Access starts 6 months after the results are published To whom: People related to academic and scientific centers Conditions: In order to write articles or design similar studies Where to obtain: By email with the person responsible for the scientific response of the study How to obtain: An answer will be given by e-mail within a period of one month after the review of the request Comments:
public Aida Iranpour
Arabi St, Yaman St, Shahid Chamran Highway, Tehran
Tehran Iran (Islamic Republic of) 1985711151 +98 21 2243 2560 iranpouraida@gmail.com Shahid Beheshti University of Medical Sciences scientific Sina Salari
Arabi St, Yaman St, Shahid Chamran highway, Tehran
Tehran Iran (Islamic Republic of) 1985711151 +98 21 2243 2560 salari.sina52@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Patients with AML of both genders in the age range of 18 to 65 years with the following conditions:• Refractory AML that has not fully recovered after induction therapy.• Relapsed AML that is not a candidate for bone marrow allogeneic transplantation.• High-risk AML (based on ELN criteria) in complete remission (CR) but currently not a candidate for allogeneic bone marrow transplantation.• Relapsed AML after bone marrow transplantation Patients with known CNS involvement with AML provided that they had been treated and the CSF was clear for at least 2 weeks prior to study enrollment ECOG performance status less than or equal to 2 Adequate performance of organs as follows:• Total bilirubin ≤ 2 mg/dL• AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN• Creatinine within normal institutional limits OR creatinine clearance ≥ 50 mL/min/1.73 m2 by Cockcroft-Gault Formula (adults) or Schwartz formula (pediatric cohort)• Oxygen saturation ≥90% on room air• Ejection fraction ≥50% Be able to stop using corticosteroids and other immunosuppressive drugs from day 3- the beginning of the trial and up to 30 days after the injection of NK cells. However, if clinically necessary, the use of low-level corticosteroids is allowed. Low-level corticosteroid use was defined as 10 mg or less of prednisone (or equivalent for other steroids) per day Not pregnant or breastfeeding Failure to receive any research drug within 14 days before the start of the clinical trial Ability to understand and willingness to sign a certified informed consent document (or if there is an authorized legal representative) 18 years 65 years Both Uncontrolled bacterial or viral infections, or known HIV, hepatitis B or C infection Uncontrolled angina, severe uncontrolled ventricular arrhythmias, or EKG indicating acute ischemia or active conduction system abnormalities New progressive pulmonary infiltrates on screening chest x-ray or chest CT scan that were not evaluated by bronchoscopy. Infiltrations attributed to infection should be stable and improving after 1 week of appropriate therapy (4 weeks for suspected or proven fungal infections) Known sensitivity to one or more study agents Active autoimmune disease that requires systemic immunosuppression treatment Known history of other cancers in the last 5 years C92.0 Acute myeloblastic leukemia Treatment - Other Intervention group: The preparation and injection of the first round of natural killer cells (NK) is done as soon as entering the study. Injections are done in three times, once a week. Before receiving NK cells, fludarabine and cyclophosphamide drugs are prescribed. NK suspended in 63 ml of 6% albumin solution is injected intravenously (central vein) for 16-23 minutes. In each NK injection, the number of injected live cells is determined based on the patient's weight. The injected NK cell is considered to be at least 10 to the power of 6 cells per kilogram of body weight. The number of injected cells is calculated based on the number of living cells. Percentage of peripheral blood blast. Timepoint: Before treatment and then 4,8 and 12 weeks after treatment. Method of measurement: Peripheral blood Flowcytometry. Hematologic parameters. Timepoint: before starting the treatment and then weekly until 6 weeks and then monthly. Method of measurement: CBC. Middle East Gene Therapy corporation Approved 2021-11-28 Vice President of Research and Technology Shahid Beheshti University of Medical Sciences (Research E Shahid Beheshti Medical university, Yaman St, Shahid Chamran Highway Tehran Tehran Iran (Islamic Republic of)