Safety and Efficacy of Expanded, Universal Donor Natural Killer Cells for Relapsed/Refractory AML

Recruiting Phase 1 Phase 2 Interventional Study
Acute Myeloid Leukemia
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
1 – 24
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
20 (estimated)
Sponsor
Nationwide Children's Hospital · Other
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About This Trial
This is a phase I/II dose escalation study designed to determine the safety and estimate the efficacy of UD-NK cells combined with FLA chemotherapy in patients age 1-24.99 with relapsed or refractory acute myeloid leukemia. PRIMARY OBJECTIVE: I. To determine the safety and recommended phase II dose of adoptive NK cell therapy using UD-NK cells in pediatric and young adult patients with relapsed/…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Patients with relapsed or primary refractory AML, including: * Patients with relapsed AML (Any patient in first or subsequent relapse are eligible. Patients with relapse after HSCT are eligible) * Primary refractory AML defined as failure to achieve a complete response af…
Contacts

Melinda C Triplet

6147226039

Melinda.Triplet@nationwidechildrens.org

CONTACT