Pharmacokinetic Study of Busulfan in Allogeneic Stem Cell Transplantation in Adult Patients With Acute Leukemia

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Shanghai Jiao Tong University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Jiong HU, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT01498016
First received: December 19, 2011
Last updated: March 18, 2014
Last verified: March 2014
  Purpose

Intravenous Busulfan (iv-Bu) is commonly used as part of preparation regimen for allogeneic hematopoietic stem cell transplantation for patients with acute leukemia. Though the pharmacokinetics data are available for population from America, Europe and Japan or Korea in Asia, there are no data in Chinese population. It is shown that high Bu concentration are associated with the toxicity such as veno-occlusion disease and lower concentration is correlated with reduced anti-leukemia effect, thus the monitoring of Bu and/or the strategy to achieve an optimal target Bu concentration are accepted to avoid toxicity while maintain the anti-leukemia effect which may overall improve the outcome of allo-SCT. Thus we conduct the pharmacokinetic study in Chinese population.


Condition Intervention Phase
Acute Leukemia
Drug: Busulfan
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pharmacokinetic Study of Intravenous Busulfan as Conditioning Regimen for Allogeneic Stem Cell Transplantation in Adult Patients With Acute Leukemia

Resource links provided by NLM:


Further study details as provided by Shanghai Jiao Tong University School of Medicine:

Primary Outcome Measures:
  • Area Under Curve (AUC) [ Time Frame: predose, 0,1,2,3,4,6,8,12,24,48,72, 96 hours post-dose ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: November 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Iv-Busulfan Drug: Busulfan
Iv busulfan 1.6mg/kg q12h D1- D4

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patient with acute myeloid or lymphoblastic leukemia in 1st or second remission
  • age 18-55 years
  • with inform consent
  • no contraindication for allogeneic transplantation: active infection, allergy to FLu/Bu/CTX, liver and renal function damage
  • HLA matched related (6/6) or unrelated donors (at least 8/10)

Exclusion Criteria:

  • age less than 18 years or over 56 years
  • HLA mismatched related donor
  • liver function/renal function damage (over 2 X upper normal range)
  • with mental disease
  Contacts and Locations
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: NCT01498016

Contacts
Contact: Jiong HU, M.D. 86-21-64370045-601818 hujiong@medmail.com.cn

Locations
China
Blood & Marrow Transplantation Center, RuiJin Hospital Recruiting
Shanghai, China, 200025
Contact: Jiong HU, M.D.    86-21-64370045 ext 601818    hujiong@medmail.com.cn   
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Investigators
Principal Investigator: Jiong HU, M.D. Rui Jin Hospital, Shanghai JiaoTong University School of Medicine
  More Information

No publications provided

Responsible Party: Jiong HU, Head, Blood &^ Marrow Transplantation Center, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT01498016     History of Changes
Other Study ID Numbers: RJH-Busulfan
Study First Received: December 19, 2011
Last Updated: March 18, 2014
Health Authority: China: Ethics Committee

Keywords provided by Shanghai Jiao Tong University School of Medicine:
acute leukemia
allogeneic stem cell transplantation
busulfan

Additional relevant MeSH terms:
Leukemia
Acute Disease
Neoplasms by Histologic Type
Neoplasms
Disease Attributes
Pathologic Processes
Busulfan
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Antineoplastic Agents
Therapeutic Uses
Myeloablative Agonists

ClinicalTrials.gov processed this record on September 18, 2014