A clinical trial of dasatinib vs. nilotinib in children with CP- and AP-CML

JRCT ID: jRCTs041190038

Registered date:06/06/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Chronic myeloid leukemia
• Date of first enrollment: 17/06/2019
• Target sample size: 65
• Study type: Interventional

Intervention(s)

Dasatinib group: Dasatinib (60 mg/m^2 for CP-CML or 80 mg/m^2 for AP-CML, QD) will be given and continued for up to 6 years (registration period + 2 years) while on study. The dose can be increased up to 80 mg/m^2 for CP- or 100 mg/m^2 for AP-CML in case of warning. In treatment failure or disease progression or intolerance, the assigned dasatinib will be switched to nilotinib or study treatment will be discontinued.

Nilotinib group:Nilotinib (230 mg/m^2, BID) will be given and continued for up to 6 years (registration period + 2 years) while on study. In treatment failure or disease progression or intolerance, the assigned nilotinib will be switched to dasatinib or study treatment will be discontinued.

Outcome(s)

• Primary Outcome: continuity of dasatinib and nilotinib

Secondary Outcome

1) the BCR-ABL1/ABL1 levels after 3 months treatment of dasatinib or nilotinib
2) the rate of BCR-ABL1/ABL1 decline after 3 months treatment of dasatinib or nilotinib
3) safety
4) cumulative achievement of hematologic response
5) cumulative achievement of cytogenetic response
6) cumulative achievement of molecular response
7) proportion of cases classified as optimal response, warning or failure
8) event-free survival rate
9) progression-free survival rate
10) overall survival rate
11) quality of life
12) long-term adverse effect

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: < 18age old
• Gender: Both

Include criteria

1) prior enrollment to JPLSG-CHM-14 study
2) BCR-ABL1 positive CML
3) chronic or accelerated phase at diagnosis and no history of disease progression
4) patients who have no history of TKI treatment other than imatinib or who are imatinib-resistant and/or intolerant
5) < 18 years of age at enrollment
6) ECOG PS 0-2 (CML-related PS 3 is allowed)
7) written informed consent obtained from patient and/or guardian

Exclude criteria

1) previously documented highly resistant mutations to dasatinib and/or nilotinib
2) QTcF >=0.45 second
3) pregnant or lactating female including who plans to be pregnant during clinical trial
4) positive allergic history to excipients of dasatinib or nilotinib
5) prior allogeneic hematopoietic stem cell transplantation for CML
6) uncontrolled or sever comorbidities
7) patients who are ineligible decided by pediatricians

Related Information

• Primary Sponsor: Keino Dai
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development,National Center for Child Health and Development