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Busulfan Pharmacokinetic Analysis and Glutathione S-transferase (GST)Genetic Polymorphism (A1,T1,M1,P1)in Adults Undergoing Hematological Bone Marrow Transplantation (HSCT).


Phase 4
18 Years
75 Years
Open (Enrolling by invite only)
Both
Busulfan Pharmacokinetic Analysis, GST Genetic Polymorphism

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Trial Information

Busulfan Pharmacokinetic Analysis and Glutathione S-transferase (GST)Genetic Polymorphism (A1,T1,M1,P1)in Adults Undergoing Hematological Bone Marrow Transplantation (HSCT).


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Hepatic Veno-Occlusive Disease, Graft versus host disease

Outcome Time Frame:

every week after HSCT up to 6 month

Safety Issue:

Yes

Authority:

Israel: Ministry of Health

Study ID:

BU-AdultPK/PGx1

NCT ID:

NCT01071486

Start Date:

August 2009

Completion Date:

October 2012

Related Keywords:

  • Busulfan Pharmacokinetic Analysis
  • GST Genetic Polymorphism
  • Busulfan
  • Glutathione S-transferase
  • Genetic polymorphism
  • HVOD
  • GVHD

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