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Reserch on switching to Flumatinib in patients with chronic myeloid leukemia who have not achieved an optimal response or intolerance after first-/second-line TKI therapy:A prospective, multicenter, observational study

Reserch on switching to Flumatinib in patients with chronic myeloid leukemia who have not achieved an optimal response or intolerance after first-/second-line TKI therapy:A prospective, multicenter, observational study

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000040558
Enrollment
Unknown
Registered
2020-12-02
Start date
2020-12-01
Completion date
Unknown
Last updated
2021-03-08

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

Conditions

chronic myeloid leukemia

Interventions

Case series:none

Sponsors

The First Affiliated Hospital of Guangxi Medical University
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. Aged >=18 years old 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 =100x10^9/L or 10% in 3 months or BCR-ABLIS>1% in 6 months)or intolerant; 4. Female patients with fertility have a negative pregnancy test (within 7 days before enrollment).

Exclusion criteria

Exclusion criteria: 1) Received stem cell transplantation before enrollment; 2) Diseases with low immune function, such as syphilis, hepatitis C and HIV; 3) T315I mutation is known; 4) Patients who participate in other clinical studies at the same time; 5) Major surgery or failure to recover from surgery within 4 weeks; 6) A history of other malignant tumors, unless another primary malignant tumor has no clinical significance or does not require active intervention; 7) Acute and chronic uncontrolled liver disease unrelated to the disease; 8) Patients during pregnancy and lactation; 9) Eastern Cooperative Oncology Group physical performance score (ECOG PS) >=3; 10) Those who are unable to follow the protocol steps or follow up on time; 11) Patients who are known to be allergic or contraindicated to study drugs (raw materials and/or excipients); 12) Other situations deemed unsuitable by the researcher.

Design outcomes

Primary

MeasureTime frame
Major Molecular Response;

Secondary

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

Countries

China

Contacts

Public ContactZhenfang Liu

The First Affiliated Hospital of Guangxi Medical University

liuliuzhenfang@163.com+86 13481082237

Outcome results

None listed

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