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Busulfan Pharmacokinetic Analysis and GST Polymorphism in Adults Undergoing Hematological Stem Cell Transplantation

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ClinicalTrials.gov Identifier: NCT01071486
Recruitment Status : Withdrawn (lack of participants)
First Posted : February 19, 2010
Last Update Posted : November 10, 2015
Sponsor:
Collaborator:
Israel Cancer Association
Information provided by (Responsible Party):
N_Krivoy, Rambam Health Care Campus

February 18, 2010
February 19, 2010
November 10, 2015
August 2009
October 2012   (Final data collection date for primary outcome measure)
Hepatic Veno-Occlusive Disease, Graft versus host disease [ Time Frame: every week after HSCT up to 6 month ]
Same as current
Complete list of historical versions of study NCT01071486 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Busulfan Pharmacokinetic Analysis and GST Polymorphism in Adults Undergoing Hematological Stem Cell Transplantation
Busulfan Pharmacokinetic Analysis and Glutathione S-transferase (GST)Genetic Polymorphism (A1,T1,M1,P1)in Adults Undergoing Hematological Bone Marrow Transplantation (HSCT).
Between 100 up to 200 adults undergoing HSCT for their primary disease will be included in this pharmacokinetic/pharmacogenetic study. In the preparative protocol Busulfan (BU)will be included as indicated in a known protocol. The GST polymorphism (A1,M1,T1 and P1) will be investigated using real time PCR. A correlation between pharmacokinetic parameters and patients polymorphism will be performed using known statistical technics for comparison. The aims of this study are, to correlate the demographic data, clinical presentation, clinical outcomes of the included individuals, the BU kinetics and the GST polymorphism and to establish an outcome "map" for those who receive HSCT for their primary disease.
Not Provided
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Busulfan Pharmacokinetic Analysis
  • GST Genetic Polymorphism
Drug: Hematological Stem Cell Transplantation
Oral or Intravenous Busulfan as part of the preparative protocol for transplantation
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
200
October 2012
October 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Malignant or Benign Diseases who need hematological stem cell transplantation as part of their treatment
  • Busulfan should be part of the preparative protocol

Exclusion Criteria:

  • Known sensitivity or allergy to Busulfan
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT01071486
BU-AdultPK/PGx1
No
Not Provided
Not Provided
N_Krivoy, Rambam Health Care Campus
Rambam Health Care Campus
Israel Cancer Association
Not Provided
Rambam Health Care Campus
November 2015

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