Chronic lymphocytic leukemia/small lymphocytic lymphoma
Conditions
Interventions
single arm:FCR combined with zanubrutinib
Sponsors
Pukou Chronic Lymphocytic Leukemia Center of Jiangsu Province Hospital; Jiangsu Province Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Male or female, 18-65 years old; 2. Confirmed diagnosis of CLL/SLL per 2018 iwCLL criteria; not treated; patient must also meet at least one of the following treatment indications: 1) Evidence of progressive bone marrow failure manifested by progressive or worsening anemia (hemoglobin 6 cm below the edge of left rib), progressive or symptomatic splenomegaly; 3) Massive lymphadenopathy (longest diameter > 10 cm), progressive or symptomatic lymphadenopathy; 4) Progressive lymphocyte increase of more than 50% within 2 months, or lymphocyte doubling time (LDT) less than 6 months.LDT should not be used as a single factor to define treatment indications in subjects with initial lymphocyte counts 38.0 degrees C for 2 weeks or more prior to screening in the absence of signs of infection; d) Nocturnal night sweats within 1 month or more prior to Screening in the absence of signs of infection; 3. Measurable lymph node lesions (CT scan); [measurable lesions according to Lugano2014 criteria: long diameter of nodular lesions > 15 mm or long diameter of extranodal lesions > 10 mm]for SLL;2018iwCLL criteria for CLL; 4. ECOG PS = 1.0 x 10^9/L; 2) Platelets >= 50 x 10^9/L; 6. Good liver and kidney function: 1) Serum creatinine = 60 mL/min (estimated according to Cockcroft-Gault formula); 2) Serum total bilirubin <= 1.5 times ULN; 3) Aspartate aminotransferase (AST), alanine aminotransferase (ALT) <= 2.5 times ULN; 7. Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier methods of contraception; abstinence) prior to study entry and for the duration of study participation; 8. Women of childbearing potential must have a negative blood or urine test at screening.
Exclusion criteria
Exclusion criteria: 1. Previously treated with anti-CLL/SLL therapy; 2. Central nervous system involvement or Richter transformation; 3. Patients requiring systemic treatment with prednisone greater than 20 mg/day or the same amount of other glucocorticoids; 4. a history of previous malignancy, except for 3 years before screening malignant tumor cure, or after adequate treatment without evidence of non-melanoma skin cancer or malignant freckles, or after adequate treatment without evidence of cervical carcinoma in situ; 5. a history of stroke, intracranial hemorrhage or severe cardiovascular disease within 6 months before screening. These include unstable angina, acute myocardial infarction, congestive heart failure New York Heart Association (NYHA) functional class III or IV; or left ventricular ejection fraction < 50%; 6. need warfarin, vitamin K antagonist anticoagulation or combined with other strong CYP3A4/5 inhibitors; 7. known human immunodeficiency virus (HIV), hepatitis C virus (HCV) infection; 8. the presence of any uncontrolled progressive systemic infection or any life-threatening disease, physical condition or organ system dysfunction considered by researchers, or interference with the absorption or metabolism of zanubrutinib capsules, or placing the study results at undue risk; 9. pregnant or lactating women, or men who plan to give birth during participation in this study or within 3 months after taking the last dose of study drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| BM uMRD;the rate of AE; | — |
Secondary
| Measure | Time frame |
|---|---|
| the rate of BM uMRD;the rate of PB uMRD;the rate of PFS at 2 year;CR;ORR;the rate of CR and uMRD; | — |
Countries
China
Contacts
Public ContactLi Jianyong
Jiangsu Province Hospital
Outcome results
None listed