Activated NK cell therapy to negate MRD in AML patients

Phase 1

Recruiting

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

• Registration Number: IRCT20230801058996N3
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

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%

Exclusion Criteria

Patients with acute myeloid leukemia-M3
Patients with low-risk acute myeloid leukemia
Patients in complete molecular remission

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.