Skip to content

Evaluation of efficacy of dose-adjusted intravenous busulfan in allogeneic hematopoietic stem cell transplantation by analyzing busulfan concentration in dried blood spot method.

Evaluation of efficacy of dose-adjusted intravenous busulfan in allogeneic hematopoietic stem cell transplantation by analyzing busulfan concentration in dried blood spot method. - Evaluation of efficacy of dose-adjusted intravenous busulfan by DBS method.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000019501
Enrollment
50
Registered
2015-11-01
Start date
2015-11-01
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

Hematological malignancy

Interventions

Sponsors

Kurashiki Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Hematological malignancy for AML, MDS, CML, ALL, ML and MM 2. Performance status(PS, ECOG) of 0-2 3. Patients without major organ dysfunction 4. T.Bil less than 2.0 mg/dL 5. AST and ALT less than 3 upper limit of the normal range 6. SCr less than 2.0mg/dl 7. Heart ejection fraction more than 40% 8. SpO2 more than 93% 9. Patients requird to have an appropriate donor identified before enrollment. (1) HLA-matched related or unrelated donor (2) 1 HLA-mismatched related or unrelated donor (3) Cord blood with nucleated cell counts more than 1.5 107/kg and mismatched HLA less than 2 10. Ability to provide informed consent.

Exclusion criteria

Exclusion criteria: 1. positive for anti-HIV antibody 2. positive for Hbs antigen 3. active another malignancy 4. uncontrollable psychological disorders 5. uncontrollable active infection 6. known hypersensitivity to busulfan 7. pregnant women 8. Patients judged as inappropriate for this study by physicians

Design outcomes

Primary

MeasureTime frame
The proportion of patients with event-free survival in 100 days after transplantation

Countries

Japan

Contacts

Public ContactAki Sato

Kurashiki Central Hospital Department of Hematology / Oncology

as14404@kchnet.or.jp086-422-0210

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026