CLINICAL TRIAL SUMMARY

MDACC Study No:2008-0450 (clinicaltrials.gov NCT No: NCT01478074)
Title: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
Principal Investigator:Dean A. Lee
Treatment Agent:ALT-801; Cytarabine; Fludarabine; G-CSF; Natural Killer Cells
Study Status:Terminated
Study Description:The goal of this clinical research study is to learn if an investigational
therapy including fludarabine, cytarabine, G-CSF (filgrastim), a donor's NK
cells, and ALT-801 can be given reliably and safely in patients with AML. NK
cells are a type of white blood cell that fights infection and cancer.

Your leftover NK cells from the leukapheresis procedures will be tested to help
show how the infused NK cells may grow, survive, and function in the
recipient's body.

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Disease Group:Blood And Marrow Transplantation; Leukemia; Pediatrics
Phase of Study:Phase I
Treatment Agents:ALT-801
Cytarabine
Fludarabine
G-CSF
Natural Killer Cells
Treatment Location:Only at MDACC
Estimated Length of Stay in Houston:One hospitalization of 2 to 6 weeks.
Supported By:Altor Bioscience Corporation
Return Visit:At least twice weekly until neutrophil counts recover, then once weekly.
Home Care:G-CSF injections may be given at home.


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Physician Name:Dean A. Lee
Dept:Pediatrics
For Clinical Trial Enrollment:713-792-6620
For General Questions about Clinical Trials:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)


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