Study S002101

A Single-center Open-label Phase I Study of ALT-801 for ex Vivo Maturation and in Vivo Retargeting of Haploidentical Natural Killer Cells Delivered Following Fludarabine, Cytarabine, and G-CSF in Patients With Relapsed/Refractory Acute Myeloid Leukemia

ClinicalTrials.gov record

Registration

Registration: NCT01478074
Study type: INTERVENTIONAL
Phase: PHASE1
Masking: NONE
Status: WITHDRAWN
Enrollment: 0
Start: 2011-11
Primary completion: 2013-10
Lead sponsor: Altor BioScience
Conditions: Acute Myeloid Leukemia
Interventions: DRUG:G-CSF; DRUG:Cytarabine; DRUG:Fludarabine; BIOLOGICAL:Donor Natural Killer (NK) cells; BIOLOGICAL:ALT-801
Results posted: FALSE

Registered primary outcomes

Maximum tolerated dose of NK cells [18 months]
Safety of delivering NK cells and ALT-801 in combination with FLAG [6 months after study completes accrual]

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