chronic myeloid leukemia
Conditions
Interventions
Flumatinib:nil
Sponsors
The First Affiliated Hospital of Kunming Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Aged (> 18 years), both male and female; 2) First diagnosed patients with Ph+CML-CP; Definition of confirmation: bone marrow cytogenetics Ph chromosome t(9;22) positive (observation of at least 20 metaphases) and/or BCR-ABL fusion gene positive; the date of first confirmation was defined as the date of sampling on the first bone marrow cytogenetics or molecular report.The definition of chronic phase meets all the following criteria: Primordial cells in peripheral blood and bone marrow were 100 *10^9/L or <100 *10^9/L) were associated with previous drug therapy; No extramedullary leukemia infiltration (except hepatosplenomegaly). 3) within six months after the diagnosis of CML; 4) received TKIs for no more than 2 weeks before enrollment; 5) Female patients with fertility had negative pregnancy test (within 7 days before enrollment); 6) The informed consent must be signed voluntarily before screening.
Exclusion criteria
Exclusion criteria: None of the following will be included: 1) T315I mutation is known to exist; 2) Received other anti-CML drugs (except hydroxyurea) for more than 2 weeks before enrollment; 3) received interferon therapy for more than 3 months before enrollment; 4) patients who participate in other clinical studies at the same time; 5) suffering from other malignancies unless another primary malignancy is currently of no clinical significance or requires active intervention; 6) having had major surgery or not recovered from previous surgery within 4 weeks; 7) Women who are pregnant, lactating or have a fertility plan; 8) Eastern Cooperative Oncology Group Physical Performance Status Score (ECOG PS) > 3; 9) those who are unable to comply with the program steps or follow up on time; 10) Patients known to be allergic or contraindicated to the study drug (APIs and/or excipients).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Very Early Molecular Response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Major Molecular Response;Major Molecular Response;safety (CTCAE5.0);Time to first complete cytogenetic remission (CcyR);EMR; | — |
Countries
China
Contacts
Public ContactZeng Yun
Outcome results
None listed