Children and Adolescents with Newly Diagnosed Chronic Phase CML or with Ph+ Leukemias Resistant to or Intolerant to Imatinib
Conditions
Brief summary
Cohort #1: Major Cytogenetic Response (MCyR) rate, defined as the proportion of all treated subjects who achieve a complete or partial cytogenetic response on study., Cohort #2: Complete Hematologic Response (CHR) rate, defined as the proportion of all treated subjects who achieve a confirmed CHR on study.
Detailed description
Cohort #1: CHR rates, Cohort #2: MCyR rates, For all Cohorts: – Rates of best cytogenetic response – Time to Major Cytogenetic Response (McyR) and duration of and McyR – Time to Complete Hematologic Response (CHR) and duration of CHR – Progression-free Survival (PFS) and Disease free survival (DFS) – Overall Survival – Rates of major and complete molecular response
Interventions
DRUGDASATINIB
DRUGDasatinib
DRUGdasatinib
Sponsors
Bristol Myers Squibb International Corporation
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cohort #1: Major Cytogenetic Response (MCyR) rate, defined as the proportion of all treated subjects who achieve a complete or partial cytogenetic response on study., Cohort #2: Complete Hematologic Response (CHR) rate, defined as the proportion of all treated subjects who achieve a confirmed CHR on study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Cohort #1: CHR rates, Cohort #2: MCyR rates, For all Cohorts: – Rates of best cytogenetic response – Time to Major Cytogenetic Response (McyR) and duration of and McyR – Time to Complete Hematologic Response (CHR) and duration of CHR – Progression-free Survival (PFS) and Disease free survival (DFS) – Overall Survival – Rates of major and complete molecular response | — |
Countries
France, Spain
Outcome results
None listed