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Brief Title CD3/CD19 Depleted or CD3 Depleted/CD56 Selected Haploidentical Donor Natural Killer (NK) Cell Based Therapy for AML Patients Not in CR
Official Title A Randomized Trial Comparing CD3/CD19 Depleted or CD3 Depleted/CD56 Selected Haploidentical Donor Natural Killer (NK) Cell Based Therapy for Adults With Acute Myelogenous Leukemia Who Have Failed 1 or 2 Induction Attempts
Principal Investigator Kosuri, Satyajit
Brief Summary This is a phase II trial designed to test the safety and efficacy (complete response [CR]) of related donor HLA-haploidentical NK-cell based therapy for the treatment of acute myelogenous leukemia (AML). Patients with newly diagnosed AML who failed to achieve a complete remission (CR) after one or two standard induction attempts receive after a preparative regimen of cyclophosphamide and fludarabine a single infusion of CD3-/CD19- NK cells or CD3-/CD56+ NK cells followed by a short course of Interleukin-2 (IL-2) to facilitate NK cell survival and expansion.
Gender All
Ages 18 Years
Enrollment 41
Accepts Healthy Volunteers No
Lead Sponsor Miltenyi Biotec GmbHIndustry
Collaborator Masonic Cancer Center, University of MinnesotaOther
Study Design
Study Phase Phase 2
Study Type Interventional
Contact Name Satyajit Kosuri, MD
Contact Phone 1-855-702-8222 (adult trials) or 1-773-702-6808 (pediatric trials)
Condition Acute Myelogenous Leukemia
Detail for Health Professional (on clinicaltrials.gov)
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