A Phase I Trial of Alloreactive Cell Infusion Following Transplantation of Haplotype Cells in Patients With Myeloid Malignancies
NCT ID: NCT00569179
Last Updated: 2015-08-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
1 participants
INTERVENTIONAL
2007-08-31
2010-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Alloreactive NK cell infusion
Escalating doses of alloreactive NK cells.
CliniMACS CD34 Reagent System
Alloreactive NK cells will be purified by a two-step immunomagnetic selection (CD3 depletion followed by CD56 selection) using the CliniMACS device.
Interventions
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CliniMACS CD34 Reagent System
Alloreactive NK cells will be purified by a two-step immunomagnetic selection (CD3 depletion followed by CD56 selection) using the CliniMACS device.
Eligibility Criteria
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Inclusion Criteria
* Identification of haploidentical donor
* LVEF \> 45% corrected
* DLCO \> 50% predicted
* Serum Creatinine \<= 2 mg/dL
* Bilirubin \< 2 x ULN
* AST, ALT \< 2 x ULN
* Age ≤ 65 years
* Performance Status 0-1
Exclusion Criteria
* Patients with active infections requiring oral or intravenous antibiotics are not eligible for enrollment until resolution of infection
* No HIV disease
* Non-pregnant and non-nursing
18 Years
65 Years
ALL
No
Sponsors
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Indiana University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Sherif Farag, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Indiana University School of Medicine
Locations
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Indiana University Cancer Center
Indianapolis, Indiana, United States
Countries
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Other Identifiers
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0612-26/ IUCRO-0179
Identifier Type: -
Identifier Source: org_study_id
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