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
PHASE2
1 participants
INTERVENTIONAL
2009-04-30
2016-08-30
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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Bone marrow processing
Bone Marrow processing using the CliniMACs device
CliniMACs device
Donor Peripheral blood progenitor cells will use CD34+ selection with the use of the CliniMACs device
Busulfan
Chemotherapy administered as a part of the HSCT conditioning regimen.
Fludarabine
Chemotherapy administered as a part of the HSCT conditioning regimen.
Cyclophosphamide
Chemotherapy administered as a part of the HSCT conditioning regimen.
ATG
Chemotherapy administered as a part of the HSCT conditioning regimen.
Interventions
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CliniMACs device
Donor Peripheral blood progenitor cells will use CD34+ selection with the use of the CliniMACs device
Busulfan
Chemotherapy administered as a part of the HSCT conditioning regimen.
Fludarabine
Chemotherapy administered as a part of the HSCT conditioning regimen.
Cyclophosphamide
Chemotherapy administered as a part of the HSCT conditioning regimen.
ATG
Chemotherapy administered as a part of the HSCT conditioning regimen.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Karnofsky or Lansy performance scale \> or = to 70%.
* Must have adequate cardiac, hepatic, renal and pulmonary function.
* Must have 7/8 or 8/8 available unrelated donor.
Exclusion Criteria
* Active CNS leukemic involvement
* Active uncontrolled viral, bacterial or fungal infection
* Positive for HIV.
ALL
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Medical College of Wisconsin
OTHER
Responsible Party
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David A. Margolis
Professor of Pediatrics and BMT Program Director
Principal Investigators
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David A Margolis, MD
Role: PRINCIPAL_INVESTIGATOR
Medical College of Wisconsin
Locations
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Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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FA 08/89
Identifier Type: -
Identifier Source: org_study_id
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