Effect of treatmen with natural killer cells in acute myeloid leukemia

Phase 2

Recruiting

• Conditions: Acute Myeloid leukemia.; Acute myeloblastic leukemia; C92.0

• Registration Number: IRCT20200417047113N2
• Lead Sponsor: Middle East Gene Therapy corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 7 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

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)

Exclusion Criteria

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.