Clinical evaluation of efficacy of dose-modified intravenous busulfan in allogeneic hematopoietic stem cell transplantation for hematological malignancy.

Clinical evaluation of efficacy of dose-modified intravenous busulfan in allogeneic hematopoietic stem cell transplantation for hematological malignancy. - Efficacy of dose-modified intravenous busulfan

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000014077

Enrollment

Registered

2014-06-15

Start date

2014-07-01

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

dose-modified intravenous busulfan

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Hematological malignancy for AML, MDS, CML and ALL 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 50% 8. SpO2 more than 93% 9. Estimated life expectancy of at least 3 months 10. 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 2 107/kg and mismatched HLA less than 2 11. 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. positive for donor-specific HLA antibody 7. previous history of hematopoietic stem cell transplantation 8. known hypersensitivity to busulfan 9. pregnant women 10. Patients judged as inappropriate for this study by physicians

Design outcomes

Primary

Measure	Time frame
The proportion of patients with event-free survival in 100 day after transplantation	—

Secondary

Measure	Time frame
The proportion 0f patients with engraftment in 100 day after transplantation The proportion of patients with grade3 or 4 adverse effects in 100 day after transplantation The proportion of patients with non-relapase mortality in 100 day and 12 month after transplantation The proportion of patients with relapase in 100 day and 12 month after transplantation	—

Countries

Japan

Contacts

Public ContactTadakazu Kondo

Kyoto University Hospital Department of Hematology and Oncology

tadakazu@kuhp.kyoto-u.ac.jp075-366-7550

Outcome results

None listed

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