chronic myeloid leukemia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients who meet all the following criteria can be included in the group: 1) Aged >= 18 years, both male and female; 2) Patients who were initially diagnosed as Ph+ CML-CP did not progress to the accelerated phase or blast phase when switching treatment; the definition of the confirmed diagnosis: Bone marrow cytogenetics Ph chromosome t(9;22) positive (observe at least 20 metaphases) and/or BCR-ABL fusion gene positive; The date of first diagnosis is defined as the sampling date on the first bone marrow cytogenetics or molecular report. The definition of chronic phase meets all the following criteria: Primitive cells in peripheral blood and bone marrow = 100 x 10^9/L or < 100 x 10^9/L but it is related to previous medical treatment; No extramedullary leukemia infiltration (except for hepatosplenomegaly). 3) Other TKI treatments are not optimal or intolerant; 4) Female patients with fertility have a negative pregnancy test (within 7 days before enrollment).
Exclusion criteria
Exclusion criteria: Those who have one of the following conditions are not selected: 1) The disease progresses to accelerated phase or blast phase; 2) T315I mutation is known; 3) Patients who participate in other clinical studies at the same time; 4) Major surgery or failure to recover from surgery within 4 weeks; 5) A history of other malignant tumors, unless another primary malignant tumor has no clinical significance or does not require active intervention; 6) Acute and chronic uncontrolled liver disease unrelated to the disease; 7) Patients during pregnancy and lactation; 8) Eastern Cooperative Oncology Group physical performance score (ECOG PS) >= 3; 9) Those who are unable to follow the protocol steps or follow up on time; 10) Patients who are known to be allergic or contraindicated to study drugs (raw materials and/or excipients); 11) Other situations deemed unsuitable by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major Molecular Response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete cytogenetic remission;Deep Molecular Response;Overall Survival;Progression-Free-Survival;Improvement of adverse reactions; | — |
Countries
China
Contacts
The Hematology Department of the Second Affiliated Hospital of the Army Medical University