Hematopoietic Stem Cell Transplantation Based on Pharmacokinetic and Pharmacodynamic Modeling

NCT01018446 | Completed Phase 1 DMC

• 1 other identifier: SNUCH-SCT-0802
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hematopoietic Stem Cell Transplantation

Keywords

Hematopoietic stem cell transplantation with busulfan based conditioning

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  1, 3, 6 and 12 months after transplantation

Study Arms (1)

Busulfan, Pharmacokinetic

EXPERIMENTAL

To develop a method to determine optimal dose of busulfan through pharmacokinetic study in hematopoietic stem cell transplantation.

Drug: Busulfan

Interventions

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

Busulfan, Pharmacokinetic

Eligibility Criteria

• Age: Up to 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

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

Location

MeSH Terms

Interventions

Busulfan

Intervention Hierarchy (Ancestors)

Butylene Glycols; Glycols; Alcohols; Organic Chemicals; Mesylates; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Hyoung Jin Kang, M.D., Ph.D

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 20, 2009
• First Posted: November 23, 2009
• Study Start: December 1, 2008
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: November 19, 2013

Record last verified: 2013-11

Locations

KR (1)