Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Conditions
Interventions
Chronic lymphocytic leukemia / small lymphocytic lymphoma group:Orelabrutinib+Rituximab
Sponsors
Anhui Provincial Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years, no gender limit; 2. Eastern Oncology Collaboration group physical status score was 0-2; 3. Histopathologically or flow cytometry confirmed chronic lymphocytic leukemia/small lymphocytic lymphoma, and CD20 was positive; 4. All subjects must be previously treated with BTK inhibitors for at least 6 months, without disease progression; 5. MRD could be detected during the screening period; 6. Life expectancy >=6 months; 7. Have normal main organ function, with the following criteria: (1) The standard of blood routine examination shall meet: 1) ANC>=0.75x10^9/L; 2) PLT>=75x10^9/L (>=50x10^9/L for patients with confirmed bone marrow infiltration); 3) Hb>=8g/dL; (2) Biochemical examination shall meet the following standards: 1) TBIL = 40 ml/min (Cockcroft-Gault formula); 8. With the ability to provide written informed consent and understand and comply with study requirements.
Exclusion criteria
Exclusion criteria: 1. Known histological transformation; 2. Received more than two BTK inhibitors treatment; 3. A history of secondary lymphoma after chemotherapy or radiotherapy for other malignancies; 4. The presence of active hepatitis B (HBV DNA>=2000 IU/mL or 10^4 copy number /mL) or hepatitis C (HCV antibody positive and HCV RNA higher than the assay limit); 5. Participated in other anti-tumor drug clinical trials within 4 weeks prior to screening; 6. Received potent CYP3A4 inhibitors within 7 days prior to screening, or received potent CYP3A4 inducers within 12 days prior to screening; 7. Renal insufficiency unrelated to lymphoma (serum creatinine concentration more than 1.5 times the upper limit of normal); liver dysfunction unrelated to lymphoma (transaminases more than 3 times the upper limit of normal and/or serum bilirubin more than 2 times the upper limit of normal); 8. Clinical symptoms of brain dysfunction, or severe mental disorders; 9. Pregnant or lactating patients; 10. The presence of any life-threatening disease, medical condition, or organ system dysfunction that the investigator considers to be likely to affect the safety of the subject or cause risk.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Undetectable rate of minimal residual lesions; | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete response;Progression free survival;Overall survival;Minimal residual lesion reduction rate;Quality of life score;Safety; | — |
Countries
China
Contacts
Public ContactDing Kaiyang
Anhui Provincial Cancer Hospital
Outcome results
None listed