Pharmacokinetic study of busulfan in allogeneic hematopoietic stem cell transplantation for patients with myeloid malignancies using once daily intravenous busulfan and fludarabine as conditioning regimen

Pharmacokinetic study of busulfan in allogeneic hematopoietic stem cell transplantation for patients with myeloid malignancies using once daily intravenous busulfan and fludarabine as conditioning regimen - IVBU1002(FB4)-PK: Pharmacokinetic study of busulfan in once daily intravenous busulfan and fludarabine phosphate

Status

Active, not recruiting

Phases

Phase 2

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000009769

Enrollment

Registered

2013-01-21

Start date

2013-01-21

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) myelodysplastic syndrome(MDS) chronic myelogenous leukemia(CML)

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Patients who are eligible for the main study and registered to it (2) Patients who give written informed consent following sufficient explanation. Patients who are under 20 years old are required to give informed consent from both persons with parental authority

Exclusion criteria

Exclusion criteria: (1) Patients who withdraw the consent to participate in this study (2) Patients who are considered as inappropriate to register by attending physicians

Design outcomes

Primary

Measure	Time frame
Proportion of patients who reach the targeted AUC range of busulfan after first and fourth dose	—

Secondary

Measure	Time frame
Relationship between pharmacokinetics of busulfan and adverse events	—

Countries

Japan

Contacts

Public ContactTakuya Yamashita

National Cancer Center Hospital Hematopoietic Stem Cell Transplantation Division

tayamash@ncc.go.jp+81-3-3542-2511

Outcome results