Study of New RIC Regimen of BuFlu in Older and/or Intolerable Patients
NCT ID: NCT01828619
Last Updated: 2013-04-10
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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UNKNOWN
60 participants
OBSERVATIONAL
2013-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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modified BuFlu, HSCT, elder/intolerable
The study group is the hematlogic malignant patients that older than 55years and/or with severe concurrent medical conditions, who will undergo HLA-matced allogenic HSCT to cure the disease. The patients will received a modified BuFlu conditioning.
modified BuFlu conditioning
The regimen consisted of hydroxyurea 80 mg/kg on d -10; cytorabine 2 g/m2 on d -9; busulfan 3.2mg/kg/day iv. ×3days( on d -8 to -6); Flu30mg/m\^2 i.v.×5days(on d-6 to-2) and semustine 250 mg/m2 on d -3.
Interventions
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modified BuFlu conditioning
The regimen consisted of hydroxyurea 80 mg/kg on d -10; cytorabine 2 g/m2 on d -9; busulfan 3.2mg/kg/day iv. ×3days( on d -8 to -6); Flu30mg/m\^2 i.v.×5days(on d-6 to-2) and semustine 250 mg/m2 on d -3.
Eligibility Criteria
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Inclusion Criteria
* will undergo HLA matced HSCT
* age \>=55years
* \<55year and intolerable to standard myeloablative conditioning
Exclusion Criteria
* cardiac EF\<50%
* creatine clearance \<50 ml/min
* ALT more than 10 times of upper normal limit
55 Years
70 Years
ALL
No
Sponsors
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Peking University People's Hospital
OTHER
Responsible Party
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FENGRONG WANG
Department of Hematology
Principal Investigators
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XiaoJun Huang, MD
Role: PRINCIPAL_INVESTIGATOR
Peking University People's Hospital, Department of Hematology
Locations
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Peking University People's Hospital
Beijing, , China
Countries
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References
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Barrett AJ, Savani BN. Stem cell transplantation with reduced-intensity conditioning regimens: a review of ten years experience with new transplant concepts and new therapeutic agents. Leukemia. 2006 Oct;20(10):1661-72. doi: 10.1038/sj.leu.2404334. Epub 2006 Jul 27.
de Lima M, Couriel D, Thall PF, Wang X, Madden T, Jones R, Shpall EJ, Shahjahan M, Pierre B, Giralt S, Korbling M, Russell JA, Champlin RE, Andersson BS. Once-daily intravenous busulfan and fludarabine: clinical and pharmacokinetic results of a myeloablative, reduced-toxicity conditioning regimen for allogeneic stem cell transplantation in AML and MDS. Blood. 2004 Aug 1;104(3):857-64. doi: 10.1182/blood-2004-02-0414. Epub 2004 Apr 8.
Other Identifiers
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PKUIH-201303
Identifier Type: -
Identifier Source: org_study_id
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