Study of pretransplant conditioning with PK-guided intravenous busulfan

Safety and efficacy of pharmacokinetically guided intravenouos busulfan once daily in pretransplant conditioning of hematopoietic malignant neoplasms.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs051200020

Enrollment

Registered

2020-05-28

Start date

2020-06-04

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

AML, ALL, MDS, CML, MF, or CMML

Interventions

Test dose

administer BU 0.8 mg/kg intravenously, and examine BU concentration value in plasma at the designated points. Day 1 and 2

adjust the dose of BU based on the AUC of test dose. Day 3 and 4 (4-days regimen)

adjust the dose of BU based on the AUC of the first dose.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients with AML, ALL, MDS, CML, MF, or CMML. 2) Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2. 3) Patients without severe organ dysfunction.

Exclusion criteria

Exclusion criteria: 1) Patients who have a history of allergic reaction to the drugs which are planned to be used in this study. 2) Patients who have underwent hematopoietic stem cell transplantation in the last 12 months. 3) AML or ALL with blasts of 30% or more in the bone marrow or peripheral blood at the registration.

Design outcomes

Primary

Measure	Time frame
Progression free survival rate at 24 months after transplantation	—

Secondary

Measure	Time frame
1)Engraftment rate at 100 days after transplantation 2)Incidence of advers events of grade 3 and 4 at 100days after transplantation 3)Progression free survival rate at 100 days after and twelve months after transplantation 4)Non-relapse mortality at 100 days after and twelve months after transplantation 5)Relapse rate at 100 days after and twelve months after transplantation 6)Overall survival rate at twelve months after transplantation 7)Incidence of infection at 100 days after and twelve months after transplantation 8)Incidence and severity of acute GVHD at 100 days after and twelve months after transplantation 9) Incidence and severity of chronic GVHD at twelve months after transplantation 10)Comparison with PK of dose-fixed BU in the once-daily regimen. 11) Comparison of PK and incidence of adverse events between traditional BU/CY conditioning and reversed conditioning (CY/BU)	—

Measure

Time frame

1)Engraftment rate at 100 days after transplantation 2)Incidence of advers events of grade 3 and 4 at 100days after transplantation 3)Progression free survival rate at 100 days after and twelve months after transplantation 4)Non-relapse mortality at 100 days after and twelve months after transplantation 5)Relapse rate at 100 days after and twelve months after transplantation 6)Overall survival rate at twelve months after transplantation 7)Incidence of infection at 100 days after and twelve months after transplantation 8)Incidence and severity of acute GVHD at 100 days after and twelve months after transplantation 9) Incidence and severity of chronic GVHD at twelve months after transplantation 10)Comparison with PK of dose-fixed BU in the once-daily regimen. 11) Comparison of PK and incidence of adverse events between traditional BU/CY conditioning and reversed conditioning (CY/BU)

—

Contacts

Public ContactJunya Kanda

Kyoto University Hospital

jkanda16@kuhp.kyoto-u.ac.jp+81-75-751-3152

Outcome results

None listed

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