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

This study is currently recruiting participants.
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

December 19, 2011
March 18, 2014
November 2011
December 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01498016 on ClinicalTrials.gov Archive Site
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Pharmacokinetic Study of Busulfan in Allogeneic Stem Cell Transplantation in Adult Patients With Acute Leukemia
Pharmacokinetic Study of Intravenous Busulfan as Conditioning Regimen for Allogeneic Stem Cell Transplantation in Adult Patients With Acute Leukemia

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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Leukemia
Drug: Busulfan
Iv busulfan 1.6mg/kg q12h D1- D4
Experimental: Iv-Busulfan
Intervention: Drug: Busulfan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
June 2015
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
No
Contact: Jiong HU, M.D. 86-21-64370045-601818 hujiong@medmail.com.cn
China
 
NCT01498016
RJH-Busulfan
No
Jiong HU, Shanghai Jiao Tong University School of Medicine
Shanghai Jiao Tong University School of Medicine
Not Provided
Principal Investigator: Jiong HU, M.D. Rui Jin Hospital, Shanghai JiaoTong University School of Medicine
Shanghai Jiao Tong University School of Medicine
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP