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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

Brief Summary:
A study of pharmacokinetics of daily intravenous busulfan

Condition or disease Intervention/treatment Phase
Hematologic Malignancy Drug: intravenous busulfan Not Applicable

Detailed Description:
A study of pharmacokinetics of daily intravenous busulfan

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Busulfan and Fludarabine as Conditioning for Allogeneic Stem Cell
Study Start Date : January 1998
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. pharmacokinetic data


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients undergoing transplantation

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00156858


Locations
Canada, Alberta
Tom Baker Cancer Centre Recruiting
Calgary, Alberta, Canada, T2N 4N2
Contact: Rachel Syme, PhD       clinical_trials_tbcc@cancerboard.ab.ca   
Sub-Investigator: Chris Brown         
Sub-Investigator: Ron Anderson         
Principal Investigator: James Russell         
Sub-Investigator: Victor Lewis         
Sponsors and Collaborators
Alberta Health Services
Investigators
Principal Investigator: James Russell, FRCp Alberta Cancerboard

ClinicalTrials.gov Identifier: NCT00156858     History of Changes
Other Study ID Numbers: 10156
717905172
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: January 19, 2012
Last Verified: September 2011

Keywords provided by AHS Cancer Control Alberta:
pharmacokinetics
transplantation
busulfan

Additional relevant MeSH terms:
Fludarabine
Fludarabine phosphate
Busulfan
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Alkylating Agents
Antineoplastic Agents, Alkylating
Myeloablative Agonists