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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01498016

Enrollment

Registered

2011-12-23

Start date

2011-11-30

Completion date

2022-06-30

Last updated

2021-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Leukemia

Keywords

acute leukemia, allogeneic stem cell transplantation, busulfan

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.

Interventions

DRUGBusulfan

Iv busulfan 1.6mg/kg q12h D1- D4

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

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

Design outcomes

Primary

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

Countries

China

Contacts

Primary ContactJiong HU, M.D.

hujiong@medmail.com.cn86-21-64370045-601818

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026