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)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230801058996N3

Enrollment

Registered

2023-10-07

Start date

2023-09-22

Completion date

Unknown

Last updated

2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute myeloid leukemia. Acute myeloblastic leukemia

Interventions

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 u

Eligibility

Sex/Gender

All

Age

12 Years to 80 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactElham Roshandel

Shahid Beheshti University of Medical Sciences

elham.roshandel@gmail.com+98 21 2303 1658

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026