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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Israel Cancer Association
Information provided by (Responsible Party):
N_Krivoy, Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01071486
First received: February 18, 2010
Last updated: May 25, 2012
Last verified: May 2012
  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: 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 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: August 2009
Estimated Study Completion Date: October 2012
Estimated 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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01071486

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

No publications provided

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
Study First Received: February 18, 2010
Last Updated: May 25, 2012
Health Authority: Israel: Ministry of Health

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

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

ClinicalTrials.gov processed this record on October 01, 2014