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

Phase 2

• Conditions: Acute Leukemia
• Interventions: Drug: Busulfan

• Registration Number: NCT01498016
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-12-19
• Study First Submitted QC: 2011-12-20
• Study First Posted: 2011-12-23
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-19
• Last Update Posted: 2021-05-21
• Primary Completion: 2022-01
• Study Completion: 2022-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Iv-Busulfan	Busulfan	iv busulfan 1.6mg/kg given q12h

Primary Outcome Measures

Name	Time	Method
Area Under Curve (AUC)	predose, 0,1,2,3,4,6,8,12,24,48,72, 96 hours post-dose	busulifan blood concentration

Trial Locations

Locations (1)

Blood & Marrow Transplantation Center, RuiJin Hospital; 🇨🇳 Shanghai, China