Peripheral Blood Stem Cell Transplantation Using the CliniMACS Device
NCT ID: NCT01071226
Last Updated: 2021-10-25
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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COMPLETED
NA
60 participants
INTERVENTIONAL
2008-05-31
2020-04-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Stratum 1
Patients receiving an unrelated donor or partially matched related donor.
CliniMACS (CD+3, CD+19 depletion)
Patient's in Stratum 1 will receive grafts that have undergone CD3+, CD19+ depletion
HSCT
Peripheral Blood Stem Cell Transplant
Stratum 2
For the patient's whose donors are haploidentical or a 2 antigen mismatched where one of the mismatches includes DRB1
CliniMACS (CD 34+ positive selection)
Patient's in Stratum 2 will receive peripheral blood progenitor cells that have undergone CD34+ selection
HSCT
Peripheral Blood Stem Cell Transplant
Interventions
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CliniMACS (CD+3, CD+19 depletion)
Patient's in Stratum 1 will receive grafts that have undergone CD3+, CD19+ depletion
CliniMACS (CD 34+ positive selection)
Patient's in Stratum 2 will receive peripheral blood progenitor cells that have undergone CD34+ selection
HSCT
Peripheral Blood Stem Cell Transplant
Eligibility Criteria
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Inclusion Criteria
* Malignant diseases: Leukemias and Lymphomas
* Non-malignant diseases: Severe Aplastic Anemia, immunodeficiencies
Exclusion Criteria
* Echo \> 27% shortening fraction
* renal function:serum creatinine \< 1.5 x for normal age
* no active untreated infection
* DLCO \> 50% of predicted value
* Hepatic: AST and ALT \< 3x upper limit of normal; bilirubin \< 2.0.
22 Years
ALL
No
Sponsors
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Children's Hospital of Philadelphia
OTHER
Medical College of Wisconsin
OTHER
Responsible Party
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Julie-An M. Talano
Associate Professor of Pediatrics and Director of Clinical Pediatric BMT Research
Principal Investigators
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Julie A Talano, MD
Role: PRINCIPAL_INVESTIGATOR
Medical College of Wisconsin
Locations
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Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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CHOP 07/216
Identifier Type: -
Identifier Source: org_study_id