MDACC Study No:2008-0450 ( 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.
Hide details for General InformationGeneral Information

Disease Group:Blood And Marrow Transplantation; Leukemia; Pediatrics
Phase of Study:Phase I
Treatment Agents:ALT-801
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.

Hide details for Study Contact InformationStudy Contact Information

Physician Name:Dean A. Lee
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.)

Show details for Study Objectives / OutcomesStudy Objectives / Outcomes
Show details for Study Status InformationStudy Status Information
Show details for Enrollment EligibilityEnrollment Eligibility
Show details for Resources and LinksResources and Links
Show details for ResultsResults