Pharmacokinetic study of intravenous busulfan in allogeneic hematopoietic stem cell transplantation for patients using intravenous busulfan and cyclophosphamide or fludarabine as conditioning regimens.

Not Applicable

• Conditions: Acute myeloid leukemia (AML),Acute lymphoblastic leukemia (ALL),Myelodysplastic syndrome (MDS), Chronic myeloid leukemia (CML)

• Registration Number: JPRN-UMIN000018693
• Lead Sponsor: Kanto Study Group for Cell Therapy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-08-20
• Study Completion: 2019-01-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

None

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The comparison of AUC of intravenous busulfan in 1st day and in 4th day using busulfan and fludarabine as conditioning regimen.

Secondary Outcome Measures

Name	Time	Method
The comparison of pharmacokinetics of busulfan in Flu/Bu and Bu/CY. The difference of individual pharmacokinetics of intravenous busulfan in 1st day and 4th day in Flu/Bu.