Reduced-Intensity Allogeneic Hematopoietic Stem Cell Transplantation for Malignant Hematological Diseases
NCT ID: NCT00582894
Last Updated: 2011-04-22
Study Results
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View full resultsBasic Information
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COMPLETED
NA
17 participants
INTERVENTIONAL
2005-02-28
2008-03-31
Brief Summary
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Detailed Description
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1. Engraftment of donor cells
2. Regimen related toxicities
Secondary Endpoints:
1. Disease-free survival
2. Overall survival
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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A
Preparative regimen of 1)Busulfex 3.2 mg/kg/day for 2 days, infused over 3 hours, on Day-6 and Day-5 2)Fludarabine 30 mg/m2/day for 5 days on Day-6 to D-2 and 3) Alemtuzumab 10 mg/day IV on days - 5 to -1
Busulfex, Fludarabine, ALemtuzumab
Busulfex 3.2 mg/kg/day for 2 days infused over 3 hours, Days -6 and Day-5 Fludarabine 30 mg/m2/day for 5 days on Day -6 to D-2 Alemtuzumab 10 mg/day IV on Days -5 to -1
Interventions
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Busulfex, Fludarabine, ALemtuzumab
Busulfex 3.2 mg/kg/day for 2 days infused over 3 hours, Days -6 and Day-5 Fludarabine 30 mg/m2/day for 5 days on Day -6 to D-2 Alemtuzumab 10 mg/day IV on Days -5 to -1
Eligibility Criteria
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Inclusion Criteria
* Ejection fraction \> 30%
* AST/ALT and bilirubin not \> 4 times normal
* Creatinine clearance greater than 70 ml/min.
* FEV1 greater than 1.0 and diffusion capacity greater than 40%
* Age 18-75 years
* Patients must be at high risk for conventional regimen related toxicity
* Malignant hematologic disease that would otherwise be considered treatable with ASCT
18 Years
75 Years
ALL
No
Sponsors
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University of Oklahoma
OTHER
Responsible Party
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University of Oklahoma Health Sciences Center
Principal Investigators
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George Selby, MD
Role: PRINCIPAL_INVESTIGATOR
University of Oklahoma
Locations
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University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Countries
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Other Identifiers
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IRB #11835
Identifier Type: OTHER
Identifier Source: secondary_id
Reduced-Intensity
Identifier Type: -
Identifier Source: org_study_id
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