Philadelphia chromosome positive (Ph+) chronic myeloid leukemia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. The subjects aged over 18 years, both male and female; 2. Patients with Ph + cml-cp diagnosed for the first time; The definition of diagnosis was: t (9; 22) positive on chromosome pH of bone marrow cytogenetics (observing at least 20 metaphases) or bcr-abl fusion gene; The first diagnosis date was defined as the sampling date on the first bone marrow cytogenetic report. 3. Patients diagnosed with CML within half a year; 4. Patients who received all TKI treatment for less than 2 weeks (except hydroxyurea and / or anagrel, and / or interferon for less than 3 months); 5. The pregnant test of female patients with fertility was negative (within 7 days before enrollment); 6. Patients who must sign informed consent before screening.
Exclusion criteria
Exclusion criteria: 1. Patients who have received TKIs drugs for more than 2 weeks before enrollment; 2. Patients who have undergone major surgery or who have not recovered from previous surgery within 4 weeks; 3. Patients with other malignant tumors, unless another primary malignant tumor has no clinical significance or does not need active intervention; 4. Women who are pregnant, lactating or have family planning; 5. Patients with ECoG PS >= 3 in the eastern cancer cooperation group; 6. Patients who are unable to follow the protocol or follow up on time; 7. Patients with known allergies or contraindications to the study drug (API and / or excipients).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major Molecular Response;Very Early Molecular Response; | — |
Secondary
| Measure | Time frame |
|---|---|
| complete cytogenetic remission;Early Molecular Response;Deep Molecular Response;Overall Survival;Progression-Free-Survival; | — |
Countries
China
Contacts
West China Hospital of Sichuan University