Skip to content

Flumatinib versus second generation tyrosine kinase inhibitor (TKI) in the treatment of newly diagnosed Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML-CP): a multicenter, non-inferior study

Flumatinib versus second generation tyrosine kinase inhibitor (TKI) in the treatment of newly diagnosed Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML-CP): a multicenter, non-inferior study

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000036212
Enrollment
Unknown
Registered
2020-08-21
Start date
2020-09-01
Completion date
Unknown
Last updated
2020-11-09

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

Conditions

Philadelphia chromosome positive (Ph+) chronic myeloid leukemia

Interventions

flumatinib group:Nil
nilotinib group:Nil
dasatinib group:nil

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All

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

MeasureTime frame
Major Molecular Response;Very Early Molecular Response;

Secondary

MeasureTime frame
complete cytogenetic remission;Early Molecular Response;Deep Molecular Response;Overall Survival;Progression-Free-Survival;

Countries

China

Contacts

Public ContactYang Yunfan

West China Hospital of Sichuan University

yangyunfan@wchscu.cn+86 15802890079

Outcome results

None listed

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