Chronic Lymphocytic Leukemia
Conditions
Interventions
Group 1 :Zebutinib + FCG scheme
Sponsors
Shandong Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The gender of the patient is not limited, and the age is 18-75 years old; 2. Must meet the diagnostic criteria of CLL; 3. The patient is an untreated or newly diagnosed patient who has not received standardized treatment, and the specific conditions are as follows: (1) Not undergoing CHOP, COP and other regimens combined with chemotherapy; (2) No regimen containing fludarabine or bendamustine was used; (3) Have not been treated with CD20 antibody or BTKi; (4) Less than 3 weeks of application of tumor canning or cyclophosphamide (alone or in combination with adrenal corticosteroids); (5) Interferon application does not exceed 6 months; (6) The above treatments do not achieve therapeutic response (PR or CR); (7) If the above treatments have been applied, the patients need to stop the treatment for 2 weeks before enrolling in the group and starting the treatment; 4. With indications for treatment of CLL, refer to the criteria of the 2018 CLL diagnosis and treatment guidelines, mainly including (meeting at least one of the following conditions): (1) Hemoglobin (not caused by hemolysis) 10.0 cm) or giant spleen (> 6 cm below the left costal margin); (4) People with systemic symptoms: continuous for two weeks/repeated fever (above 38°C) and not caused by infection, or night sweats and/or weight loss > 10% within 6 months; (5) The disease progresses rapidly, such as lymph node enlargement of more than 50% within 2 months, and/or absolute doubling time of peripheral blood lymphocytes = 3 months.
Exclusion criteria
Exclusion criteria: 1. Malignant tumors other than CLL (including active central nervous system lymphoma) have been diagnosed or treated in the past year; 2. There has been clinical evidence that transformation of large cell lymphoma occurs, or progression to prolymphocytic leukemia (PLL); 3. Suffering from immune hemolysis or immune thrombocytopenia, and need to be treated with glucocorticoids; 4. Non-lymphoma-related liver and kidney damage: alanine aminotransferase (ALT) > 3 times the upper limit of normal value, aspartate aminotransferase (AST) > 3 times the upper limit of normal value, total bilirubin (TBIL) > 2 times the upper limit of normal value , serum creatinine > 1.5 times the upper limit of normal; 5. Other serious medical diseases that will affect the study (such as uncontrolled diabetes, gastric ulcer, other serious cardiopulmonary diseases, etc.). The right to judge and decide belongs to the researcher; 6. Severe or uncontrolled infection; 7. Central nervous system dysfunction with clinical manifestations; 8. Continuous uncontrolled bleeding; 9. History of life-threatening hemorrhage, especially caused by irreversible reasons; 10. High doses of several anticoagulants are required and cannot be temporarily suspended; 11. The patient has undergone major surgery in the past 30 days (excluding lymph node biopsy); 12. Pregnant or lactating women, women of childbearing age who have not taken contraceptive measures; 13. Hypersensitivity to the drugs used.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall response rate, ORR;Complete response rate, CRR;Overall survival rate;Molecular biology remission rate;Duration of tumor remission;Treatment related side effects; | — |
Contacts
Public ContactZengjun Li
Shandong Cancer Hospital
Outcome results
None listed