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

This study has been withdrawn prior to enrollment.
(lack of participants)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01071486
First Posted: February 19, 2010
Last Update Posted: November 10, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Israel Cancer Association
Information provided by (Responsible Party):
N_Krivoy, Rambam Health Care Campus
  Purpose
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.

Condition Intervention Phase
Busulfan Pharmacokinetic Analysis GST Genetic Polymorphism Drug: Hematological Stem Cell Transplantation Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Busulfan Pharmacokinetic Analysis and Glutathione S-transferase (GST)Genetic Polymorphism (A1,T1,M1,P1)in Adults Undergoing Hematological Bone Marrow Transplantation (HSCT).

Resource links provided by NLM:


Further study details as provided by N_Krivoy, Rambam Health Care Campus:

Primary Outcome Measures:
  • Hepatic Veno-Occlusive Disease, Graft versus host disease [ Time Frame: every week after HSCT up to 6 month ]

Enrollment: 0
Study Start Date: August 2009
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Hematological Stem Cell Transplantation
    Oral or Intravenous Busulfan as part of the preparative protocol for transplantation
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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): NCT01071486


Locations
Israel
Rambam Health Care Campus
Haifa, Israel, 31096
Sponsors and Collaborators
Rambam Health Care Campus
Israel Cancer Association
  More Information

Responsible Party: N_Krivoy, Clinical Pharmacology Unit, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01071486     History of Changes
Other Study ID Numbers: BU-AdultPK/PGx1
First Submitted: February 18, 2010
First Posted: February 19, 2010
Last Update Posted: November 10, 2015
Last Verified: November 2015

Keywords provided by N_Krivoy, Rambam Health Care Campus:
Busulfan
Glutathione S-transferase
Genetic polymorphism
HVOD
GVHD

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