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Busulfan and Fludarabine as Conditioning for Allogeneic Stem Cell Transplantation: a Pharmacokinetic Study

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ClinicalTrials.gov Identifier: NCT00156858
Recruitment Status : Unknown
Verified September 2011 by AHS Cancer Control Alberta.
Recruitment status was:  Recruiting
First Posted : September 12, 2005
Last Update Posted : January 19, 2012
Sponsor:
Information provided by:
AHS Cancer Control Alberta

Tracking Information
First Submitted Date  ICMJE September 8, 2005
First Posted Date  ICMJE September 12, 2005
Last Update Posted Date January 19, 2012
Study Start Date  ICMJE January 1998
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 8, 2005)
pharmacokinetic data
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00156858 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Busulfan and Fludarabine as Conditioning for Allogeneic Stem Cell Transplantation: a Pharmacokinetic Study
Official Title  ICMJE Busulfan and Fludarabine as Conditioning for Allogeneic Stem Cell
Brief Summary A study of pharmacokinetics of daily intravenous busulfan
Detailed Description A study of pharmacokinetics of daily intravenous busulfan
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hematologic Malignancy
Intervention  ICMJE Drug: intravenous busulfan
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 8, 2005)
200
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE December 2010
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • patients undergoing transplantation

Exclusion Criteria:

-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 70 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00156858
Other Study ID Numbers  ICMJE 10156
717905172
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Alberta Health Services
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: James Russell, FRCp Alberta Cancerboard
PRS Account AHS Cancer Control Alberta
Verification Date September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP