Myeloid Leukemia, Chronic, Chronic-Phase
Conditions
Keywords
Chronic phase chronic myelogenous leukemia (CML)
Brief summary
The purpose of this study is to find out whether adding a new drug, dasatinib, to imatinib is safe, and whether the combination of the two drugs will help decrease the number of cells that contain the Philadelphia chromosome.
Interventions
DRUGDasatinib in combination with imatinib
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* males and females, 18 or older * chronic phase Ph+ or BCR-ABL positive CML * current complete hematologic response to imatinib * lack of major molecular response * on imatinib for at least one year * on the same imatinib dose for at least 6 months * adequate hepatic and renal function
Exclusion criteria
* History of accelerated or blast phase CML * Serious uncontrolled medical disorder or active infection * Significant cardiovascular disease or bleeding disorder * Concurrent use of medications at risk of causing Torsades de Pointe
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the maximum tolerated dose (MTD) and recommended dose of dasatinib when combined with imatinib in chronic phase CML patients. | — |
Secondary
| Measure | Time frame |
|---|---|
| identify dose limiting toxicities | — |
| characterize plasma pharmacokinetics of dasatinib and imatinib in month 1 | — |
| measure major molecular response rate | — |
| assess safety and tolerability of dasatinib and imatinib administered in combination throughout study | — |
| characterize mutations in the BCR-ABL gene | — |
| evaluate progressive free survival and overall survival | — |
| measure the major cytogenetic response rate | — |
Countries
United States
Outcome results
None listed