Chronic lymphocytic leukemia, CLL
Conditions
Interventions
Group of BTKi+BCL2i:None
Sponsors
The Second Xiangya Hospital, Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Age >18 years, any gender. 2. Diagnosis of CLL or SLL according to the iwCLL 2018 criteria. 3. Patients with CLL/SLL who have previously received venetoclax combined with a BTK inhibitor. 4. Detectable MRD in peripheral blood by flow cytometry (>10^-4). 5. ECOG performance status =50 mL/min (calculated or measured); (3) ALT and AST =50 × 10^9/L (no platelet transfusion within 2 weeks); (2) Absolute neutrophil count >=1 × 10^9/L (without growth factors), unless due to CLL marrow infiltration (CLL cells >=80% in bone marrow); (3) Hemoglobin >=80 g/L. 8. Adequate cardiovascular function: (1) No uncontrolled arrhythmias; (2) Left ventricular ejection fraction (LVEF) >=35% by echocardiography; (3) NYHA heart failure class <=2. 9. Ability to provide signed informed consent and comply with protocol-required follow-up.
Exclusion criteria
Exclusion criteria: 1.Evidence of Richter transformation; 2.Active malignancy (other than CLL) requiring systemic therapy, except for cured carcinoma in situ of the cervix, basal cell carcinoma of the skin, localized squamous cell carcinoma of the skin, or prior radical treatment. 3.Pregnancy or breastfeeding; 4.Known human immunodeficiency virus (HIV) infection; 5.Uncontrolled autoimmune disease (autoimmune hemolytic anemia or immune thrombocytopenia) requiring >20 mg/day prednisone or equivalent corticosteroid, including within 7 days before the first venetoclax dose. 6.Concurrent use of warfarin or other vitamin K antagonists or oral anticoagulants. 7.Malabsorption syndrome or other conditions that preclude enteral administration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| uMRD rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival, PFS;Complete response rate, CRR; | — |
Countries
China
Contacts
Public ContactHongling Peng
The Second Xiangya Hospital, Central South University
Outcome results
None listed