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Reserch on switching to flumatinib in patients with chronic myeloid leukemia in chronic phase (CML-CP)

Outcomes of switching to flumatinib in patients with chronic myeloid leukemia in chronic phase (CML-CP) who have not achieved an optimal response or intolerant to prior tyrosine kinase inhibitor treatment: a prospective observational study

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000039224
Enrollment
Unknown
Registered
2020-10-22
Start date
2020-10-20
Completion date
Unknown
Last updated
2021-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic myeloid leukemia

Interventions

1:Take flumatinib regularly

Sponsors

The Hematology Department of the Second Affiliated Hospital of the Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

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

MeasureTime frame
Major Molecular Response;

Secondary

MeasureTime frame
Complete cytogenetic remission;Deep Molecular Response;Overall Survival;Progression-Free-Survival;Improvement of adverse reactions;

Countries

China

Contacts

Public ContactXi Zhang

The Hematology Department of the Second Affiliated Hospital of the Army Medical University

zhangxxi@sina.com+86 13808310064

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026