Chronic myeloid leukemia
Conditions
Interventions
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
Sponsors
Koh Katsuyoshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| continuity of dasatinib and nilotinib | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Contacts
Public ContactDai Keino
Kanagawa Children's Medical Center
Outcome results
None listed