Hematopoietic Stem Cell Transplantation Based on Pharmacokinetic and Pharmacodynamic Modeling
This study has been completed.
Information provided by:
Seoul National University Hospital
First received: November 20, 2009
Last updated: November 17, 2013
Last verified: November 2013
In this study the investigators plan to develop a method to determine optimal busulfan dose through pharmacokinetic study.
Hematopoietic Stem Cell Transplantation
||Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Determination of Optimal Busulfan Dose Using Pharmacokinetic Modeling in Hematopoietic Stem Cell Transplantation
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||February 2012 (Final data collection date for primary outcome measure)
Experimental: Busulfan, Pharmacokinetic
To develop a method to determine optimal dose of busulfan through pharmacokinetic study in hematopoietic stem cell transplantation.
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
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.
|Ages Eligible for Study:
||up to 19 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
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: NCT01018446
|Seoul National University Hospital
|Seoul, Daehangno, Jongno-gu, Korea, Republic of, 101 |
Seoul National University Hospital
||Hyoung Jin Kang, M.D., Ph.D
||Seoul National University Hospital
No publications provided
||Korea National Enterprise for Clinical Trials
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 20, 2009
||November 17, 2013
||Korea: Food and Drug Administration
Keywords provided by Seoul National University Hospital:
Hematopoietic stem cell transplantation with busulfan based conditioning
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 28, 2014
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action