Study of pretransplant conditioning with PK-guided intravenous busulfan

JRCT ID: jRCTs051200020

Registered date:28/05/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: AML, ALL, MDS, CML, MF, or CMML
• Date of first enrollment: 04/06/2020
• Target sample size: 80
• Study type: Interventional

Intervention(s)

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.

Outcome(s)

• Primary Outcome: Progression free survival rate at 24 months after transplantation

Secondary Outcome

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)

Key inclusion & exclusion criteria

• Age minimum: >= 16age old
• Age maximum: <= 70age old
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Kanda Junya