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

Pharmacokinetic study of intravenous busulfan in allogeneic hematopoietic stem cell transplantation for patients using intravenous busulfan and cyclophosphamide or fludarabine as conditioning regimens. - Pharmacokinetic study of intravenous busulfan as conditioning regimens (KSGCT1502)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000018693

Enrollment

Registered

2015-08-20

Start date

2015-08-20

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

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

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients who received 1st allogeneic hematopoietic stem cell transplantation using Flu/ivBu or ivBu/CY. 2. Busulfan is given intravenously (0.8mg/kg) every six hours for four days (total dose 12.8mg/kg). 3. Patients diagnosed AML, ALL, MDS, CML. No limitation of disease status at transplantation. 4. Patients more than the age of 15 years at informed consents. 5. No limitation of stem cell source.

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

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

Secondary

Measure	Time frame
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.	—

Countries

Japan

Contacts

Public ContactKikuchi Taku

Kanto Study Group for Cell Therapy Trial Office

taku_k_1123@mac.com03-3353-1211

Outcome results