Hematopoietic Stem Cell Transplantation Based on Pharmacokinetic and Pharmacodynamic Modeling

Sponsor

Seoul National University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01018446

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hematopoietic Stem Cell Transplantation	Drug: Busulfan	Phase 1

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2008

Actual Primary Completion Date :

Feb 1, 2012

Actual Study Completion Date :

Feb 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Busulfan, Pharmacokinetic To develop a method to determine optimal dose of busulfan through pharmacokinetic study in 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

Arm

Intervention/Treatment

Experimental: Busulfan, Pharmacokinetic

To develop a method to determine optimal dose of busulfan through pharmacokinetic study in 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

Outcome Measures

Primary Outcome Measures

To develop a method to determine optimal dose of busulfan through pharmacokinetic study in hematopoietic stem cell transplantation. [For 4 days used Buslufan through pharmacokinetic study in hematopoietic stem cell transplantation]

Secondary Outcome Measures

To evaluate survival, toxicities, engraftment rate of patients received optimal dose of busulfan. [1, 3, 6 and 12 months after transplantation]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 19 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul	Daehangno, Jongno-gu	Korea, Republic of	101

Sponsors and Collaborators

Seoul National University Hospital

Investigators

Principal Investigator: Hyoung Jin Kang, M.D., Ph.D, Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01018446

Other Study ID Numbers:

SNUCH-SCT-0802

First Posted:

Nov 23, 2009

Last Update Posted:

Nov 19, 2013

Last Verified:

Nov 1, 2013

Keywords provided by , ,

Hematopoietic stem cell transplantation with busulfan based conditioning

Additional relevant MeSH terms:

Busulfan

Study Results

No Results Posted as of Nov 19, 2013