drugset / Trial / NCT01498016

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

NCT01498016 ↗

NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2011-11
Primary completion
2022-01
Completion
2022-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Busulfan Small molecule 1.6 mg/kg Intravenous

Indications