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Hematopoietic Stem Cell Transplantation Based on Pharmacokinetic and Pharmacodynamic Modeling

This study has been completed.
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01018446
First received: November 20, 2009
Last updated: February 27, 2013
Last verified: February 2013
History of Changes

November 20, 2009
February 27, 2013
December 2008
February 2012   (final data collection date for primary outcome measure)
To develop a method to determine optimal dose of busulfan through pharmacokinetic study in hematopoietic stem cell transplantation. [ Time Frame: For 4 days used Buslufan through pharmacokinetic study in hematopoietic stem cell transplantation ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01018446 on ClinicalTrials.gov Archive Site
To evaluate survival, toxicities, engraftment rate of patients received optimal dose of busulfan. [ Time Frame: 1, 3, 6 and 12 months after transplantation ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Hematopoietic Stem Cell Transplantation Based on Pharmacokinetic and Pharmacodynamic Modeling
Determination of Optimal Busulfan Dose Using Pharmacokinetic Modeling in Hematopoietic Stem Cell Transplantation

In this study the investigators plan to develop a method to determine optimal busulfan dose through pharmacokinetic study.

Busulfan is a highly toxic drug with narrow therapeutic window used for the conditioning of hematopoietic stem cell transplantation. High exposure is associated with systemic toxicity such as veno-occlusive disease (VOD) and underexposure is associated with graft failure or relapse. In this study we plan to develop a method to determine optimal busulfan dose through pharmacokinetic study.
Interventional
Phase 1
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hematopoietic Stem Cell Transplantation
Drug: Busulfan
First dose: busulfan (120 mg/m2 ivs once daily) (if age<1 yr: 80 mg/ m2) Second to forth dose: according to the daily pharmacokinetic study
Experimental: Busulfan, Pharmacokinetic
To develop a method to determine optimal dose of busulfan through pharmacokinetic study in hematopoietic stem cell transplantation.
Intervention: Drug: Busulfan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
February 2012
February 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Hematopoietic stem cell transplantation with busulfan based conditioning
  2. Age: no limits.
  3. Performance status: ECOG 0-2.
  4. Patients must be free of significant functional deficits in major organs, but the following eligibility criteria may be modified in individual cases. 1. Heart: a shortening fraction > 30% and ejection fraction > 45%. 2. Liver: total bilirubin < 2 × upper limit of normal; ALT < 3 × upper limit of normal. 3. Kidney: creatinine <2 × normal or a creatinine clearance (GFR) > 60 ml/min/1.73m2.
  5. Patients must lack any active viral infections or active fungal infection.
  6. Appropriate donor is available: Matched in 6/6 of A, B, DR loci.
  7. Patients (or one of parents if patients age < 19) should sign informed consent.

Exclusion Criteria:

  1. Pregnant or nursing women.
  2. Malignant or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy.
  3. Psychiatric disorder that would preclude compliance.
Both
up to 19 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01018446
SNUCH-SCT-0802
Yes
Korea National Enterprise for Clinical Trials
Seoul National University Hospital
Not Provided
Principal Investigator: Hyoung Jin Kang, M.D., Ph.D Seoul National University Hospital
Seoul National University Hospital
February 2013

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