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

Acute Leukemia Clinical Trial

Official title:

Pharmacokinetic Study of Intravenous Busulfan as Conditioning Regimen for Allogeneic Stem Cell Transplantation in Adult Patients With Acute Leukemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01498016
• Other study ID #: RJH-Busulfan
• Status: Recruiting
• Phase: Phase 2
• Start date: November 2011
• Est. completion date: June 2022

Study information

• Verified date: May 2021
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: Jiong HU, M.D.
• Phone: 86-21-64370045-601818
• Email: hujiong[@]medmail.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

All patients received intravenous Busulfan based conditioning regimen for allogeneic stem cell transplantation.

Intravenous Busulfan (iv-Bu) was given 1.6mg/kg twice daily for 4 days as in the conditioning regimen.

Blood samples were obtained after first and 7th dose of iv Bulsulfan.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Disease
• Acute Leukemia
• Leukemia

Intervention

Drug:
• Busulfan
Iv busulfan 1.6mg/kg q12h D1- D4

Locations

Country	Name	City	State
China	Blood & Marrow Transplantation Center, RuiJin Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under Curve (AUC)	busulifan blood concentration	predose, 0,1,2,3,4,6,8,12,24,48,72, 96 hours post-dose