CML-CP
Conditions
Interventions
Experimental group:Orebabitinib
Sponsors
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Male and non-pregnant or non-lactating female, aged >= 18 years; 2. Patients with Ph+ and/or BCR-ABL fusion gene positive CML-CP, and patients in chronic stage at the time of enrollment (refer to Table 3 for specific criteria); 3. Drug resistance or intolerance to one treatment (imatinib, nilotinib, dasatinib and flumatinib, etc.) (refer to Schedule 4 for specific definitions); 4. Negative serum pregnancy test in fertile female patients (within 7 days before enrollment); 5. ECOG score = 6.0 g/dL; (2) Platelet >= 50 x 10^9/L; (3) Serum creatinine 1.5 x ULN, 24-hour creatinine clearance >= 50 mL/min (Cockcroft-Gault formula, see Appendix 3); (4) Serum albumin >= 3.0 g/dL; (5) Serum total bilirubin 50%, pulmonary artery systolic pressure <= 50 mmHg; (9) QTcF or QTcB interval: male <= 450 ms, female <= 470 ms; 8. Informed consent must be signed voluntarily before screening; 9. Subjects must be willing and able to complete study procedures and follow-up examinations.
Exclusion criteria
Exclusion criteria: 1. CML patients with prior AP and BP diagnosis; 2. There are known T315I mutations; 3. Received stem cell transplantation before enrollment; 4. Syphilis (active), hepatitis C (active), HIV and other diseases with low immune function; 5. Patients who also participate in other clinical studies; 6. Have undergone major surgery or have not recovered from surgery within 4 weeks prior to the first administration; 7. Patients with coagulation disorders, or a history of non-CML-related hemorrhagic diseases within 3 months prior to first administration; 8. A history of other malignancies, unless another primary malignancy is not currently clinically significant or does not require active intervention; 9. Subjects requiring long-term use of immunosuppressive therapy in addition to short-course treatment with prescription corticosteroids (defined as a daily dose of less than 30 mg of prednisone or an equivalent dose of another corticosteroid within 14 days); 10. Cytologically or pathologically confirmed active central nervous system (CNS) disease, in the absence of CNS disease, lumbar puncture is not required; 11. The diagnosis of another malignant tumor (patients who have been cured for 5 years, or completely resected non-melanoma skin cancer or successfully treated carcinoma in situ, or controlled prostate cancer, the investigator determined that the efficacy and safety evaluation of this study would not be affected can be included in this study); 12. Women with birth plans; 13. Inability to follow protocol steps or follow up on time; 14. Patients with known allergies or contraindications to the study drug (API and/or excipients); 15. Other conditions considered unsuitable for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete cytogenetic response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Endpoint of validity;Safety assessment; | — |
Countries
China
Contacts
Public ContactYu Hu, Weiming Li
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed