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Completed

NCT Number: NCT01018446

Hematopoietic Stem Cell Transplantation Based on Pharmacokinetic and Pharmacodynamic Modeling

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

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Key information

Conditions

Hematopoietic Stem Cell Transplantation

Age range

Up to 19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital

Seoul, Daehangno, Jongno-gu, 101, South Korea

About this 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hematopoietic stem cell transplantation with busulfan based conditioning
  • Age: no limits.
  • Performance status: ECOG 0-2.
  • 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.
  • Patients must lack any active viral infections or active fungal infection.
  • Appropriate donor is available: Matched in 6/6 of A, B, DR loci.
  • Patients (or one of parents if patients age < 19) should sign informed consent.

Exclusion criteria

  • Pregnant or nursing women.
  • Malignant or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy.
  • Psychiatric disorder that would preclude compliance.

Treatment and study plan

busulfan

Drug

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

Primary outcomes

  1. 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

Secondary outcomes

  1. To evaluate survival, toxicities, engraftment rate of patients received optimal dose of busulfan.

    Time frame: 1, 3, 6 and 12 months after transplantation

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Determination of Optimal Busulfan Dose Using Pharmacokinetic Modeling in Hematopoietic Stem Cell Transplantation

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Nov 23, 2009
Registry last updated
Nov 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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