The Acute Myeloid Leukemia (AML) immune cell therapy using allogeneic ex-vivo expanded Natural Killer Cells (NK cells) transplantatio

Phase 1

Recruiting

• Conditions: Acute Myeloid Leukemia (AML).; Acute myeloblastic leukemia; C92.0

• Registration Number: IRCT20200621047859N3
• Lead Sponsor: Motamed Cancer Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1- Age 18 to 70 years
2. Drug-resistant AML patients with no response to 2 treatments line or recurrent cases that can not be candidates for standard therapies or bone marrow transplants
3- The toxicity of chemotherapy regimens ( such as severe cytopenia) should be assigned and it would be checked as a regimen with no significant side effects.
4- PS=2[Performance Status (PS)]
5- The results of these tests should be available:• [glomerular filtration rate (GFR)] GFR=60 or CR=2 mg / dl• ALT <2.5XULN / Bid=2• O2Sat> 92% in room air• Cardiac classification status (III> NHC) or [ejection fraction]EF> 50%• Negative pregnancy test• Negative HIV testing

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Possible symptoms of hyper-sensitivity and allergy after injection. Timepoint: Daily until the third day after the injection and then weekly until the day +90 after the injection. Method of measurement: Using CTCAE check list.;Decrease of tumor burden. Timepoint: A week after injection and every month until 3 months. Method of measurement: Physical Examination, Flow cytometry, CBC.;Graft versus host disease (GVHD) symptoms. Timepoint: Daily until the third day after the injection and then weekly until the day +90 after the injection. Method of measurement: Physical examination - Imaging - Laboratory tests.