The safety and efficacy of dasatinib 50mg as first-line treatment in newly diagnosed CML-CP patients

The safety and efficacy study of Dasatinib 50mg for newly diagnosed CML-CP patients

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2200060751

Enrollment

Unknown

Registered

2022-06-09

Start date

2022-06-01

Completion date

Unknown

Last updated

2023-03-26

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

Conditions

Chronic myeloid leukemia

Interventions

Group A:dasatinib 50 mg qd PO

Eligibility

Sex/Gender

All

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Aged >= 18 years (if the general situation is good, age restriction could be flexible); 2. Newly diagnosed CML in chronic phase, diagnosed less than 3 months, not using other anti-tumor drugs except hydroxyurea and interferon, other TKI use for no more than one month; 3. No accelerated and acute phase status; 4. ECOG score was less than 2; 5. Patients are voluntary patients, after fully understanding the nature of the trial, the purpose of the trial, the expected possible benefits and possible risks, and the results of previous studies, they voluntarily agree to consent to participate in this trial and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with combined severe hepatic or renal abnormalities (ALT>UTR, AST>3UTR, EGFR 460 ms) on ECG prior to enrollment; 3. History of major bleeding disorders unrelated to CML; 4. Patients with a combination of other tumors; 5. Patients with active, uncontrolled psychiatric disorders including: psychosis, major depressive disorder and bipolar disorder; 6. Other conditions deemed by the investigator to be inappropriate for participation in clinical observation; 7. Participation in other clinical trials within 4 weeks prior to the start of this study.

Design outcomes

Primary

Measure	Time frame
the proportion of patients who achieve a major molecular remission;	—

Secondary

Measure	Time frame
Major molecular remission (MMR) rates;MR4.0 and MR4.5 ratios;Complete cytogenetic remission (CCyR) rates;Complete hematological remission (CHR) rates;Time to remission;Duration of remission;Event-free survival (EFS%);transformation-free survival (TFS%);adverse reactions;quality of life assessment;progression-free survival (PFS%);overall survival (OS%);	—

Countries

China

Contacts

Public ContactLi Weiming

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

lee937@126.com+86 13098815546

Outcome results

None listed

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