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Feasibility, safety, effectiveness and toxicity of Post-transplant Expanded, Activated Haploidentical Natural Killer Cells Infusion in Haploidentical Hematopoietic Stem Cell Transplantation for Pediatric Patients with Acute Myeloid Leukemia: A Pilot Study

Feasibility, safety, effectiveness and toxicity of Post-transplant Expanded, Activated Haploidentical Natural Killer Cells Infusion in Haploidentical Hematopoietic Stem Cell Transplantation for Pediatric Patients with Acute Myeloid Leukemia: A Pilot Study

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20140818018842N33
Enrollment
5
Registered
2023-04-03
Start date
2023-03-21
Completion date
Unknown
Last updated
2023-05-01

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

Conditions

Acute Myeloid Leukemia. Acute myeloid leukemia

Interventions

Intervention group: Pediatric Patients with Acute Myeloid Leukemia who are candidate to recieve Haploidentical Hematopoietic Stem Cell Transplantation 1. Haploidentical dono

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years

Inclusion criteria

Inclusion criteria: Age = 18 years old. Patients must have a diagnosis of AML other than acute promyelocytic leukemia (APL) according to WHO criteria and should be a candidate for their first allogenic haploidentical HSCT. All patients must have adequate organ function defined as:a. Renal Function: Age-adjusted serum creatinine = to 1.5 x normal for age/gender OR creatinine clearance or GFR greater than or equal to 60 cc/min/1.73m2b. Liver Function: Total bilirubin = 1.5 x normal for age, AND Alanine aminotransferase (ALT) is no more than 2 times the upper limit of normal and Aspartate transaminases (AST) is no more than 2 times the upper limit of normal.c. Cardiac Function: Normal ejection fraction documented by either echocardiogram or radionuclide MUGA evaluation OR Normal fractional shortening documented by echocardiogramd. Pulmonary Function: No dyspnea at rest, no oxygen requirement. Karnofsky or Lansky performance score of greater than or equal to 50. Potentially available haploidentical family donor (child/ sibling), willing and fit for NK cell donation At least two weeks since receipt of any biological therapy, systemic chemotherapy, and/or radiation therapy.

Exclusion criteria

Exclusion criteria: Pregnancy: Quantitative Serum B-HCG must be negative in girls who are post-menarchal Breast feeding women are not eligible. Active or uncontrolled infection Patient declines participation Second HSC

Design outcomes

Primary

MeasureTime frame
Relapse free survival. Timepoint: 1 year. Method of measurement: spss.—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAzadeh Kiumarsi

Tehran University of Medical Sciences

akiumarsi@sina.tums.ac.ir+98 912 389 0394

Outcome results

None listed

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