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

Phase 1

Recruiting

• Conditions: Acute Myeloid Leukemia.; Acute myeloid leukemia; C92.0

• Registration Number: IRCT20140818018842N33
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 1 May 2023

Recruitment & Eligibility

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

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relapse free survival. Timepoint: 1 year. Method of measurement: spss.