Development of analysing blood concentration of iv busulfan in patients by dried blood spot method

Development of analysing blood concentration of iv busulfan in patients by dried blood spot method - Analysis of blood concentration of busulfan by DBS method (DBS13)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000015034

Enrollment

Registered

2014-09-02

Start date

2014-04-21

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, Chronic myeloid leukemia, Myelodysplastic syndrome, Acute lymphoblastic leukemia, Chronic lymphocytic leukemia, Malignant lymphoma

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: *Diagnosis of either Acute myeloid leukemia, Chronic myeloid leukemia, Myelodysplastic syndrome, Acute lymphoblastic leukemia, Chronic lymphocytic leukemia, Malignant lymphoma *Performance status (ECOG) ranging from 0 to 2 *Without severe comorbidity *T.Bil=<2.0 mg/dL, AST?ALT=<3xULN, CCr>=30 mL/min, Cardiac output>=50%, SpO2>=95% *At least 3 months lifespan is expected. *Hematopoietic stem cell transplantation recipients with regimen including 3.2 mg/kg-12.8 mg/kg of BU (0.8 mg/kg/dose) *Written informed consent for participation is obtained

Exclusion criteria

Exclusion criteria: *History of drug hypersensitivity to the drugs used in the treatment *Dose of single injection is not 0.8 mg/kg for 2 hour infusion *Patients who is not appropriate for entering the study by attending physician

Design outcomes

Primary

Measure	Time frame
Comparative analysis of pharmacokinetics of BU by HPLC and DBS methods	—

Countries

Japan

Contacts

Public ContactNaoyuki Uchida

Toranomon Hospital Department of Hematology

nuchida@toranomon.gr.jp03-3588-1111(+81-3-3588-1111)

Outcome results