A clinical trial of dasatinib vs. nilotinib in children with CP- and AP-CM
- Conditions
- Chronic myeloid leukemia
- Registration Number
- JPRN-jRCTs041190038
- Lead Sponsor
- Keino Dai
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 65
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method continuity of dasatinib and nilotinib
- Secondary Outcome Measures
Name Time Method 1) the BCR-ABL1/ABL1 levels after 3 months treatment of dasatinib or nilotinib<br>2) the rate of BCR-ABL1/ABL1 decline after 3 months treatment of dasatinib or nilotinib<br>3) safety<br>4) cumulative achievement of hematologic response<br>5) cumulative achievement of cytogenetic response<br>6) cumulative achievement of molecular response<br>7) proportion of cases classified as optimal response, warning or failure<br>8) event-free survival rate<br>9) progression-free survival rate<br>10) overall survival rate<br>11) quality of life<br>12) long-term adverse effect