IRCT20140818018842N33
Recruiting
Phase 1
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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Tehran University of Medical Sciences
- Enrollment
- 5
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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