Chronic Lymphocytic Leukemia
Conditions
Interventions
Single-arm research Group:Lisafoclax 600mg once daily orally with dose escalation: 20mg on day 1, 50mg on day 2, 100mg on day 3, 200mg on day 4, 400mg on day 5, and 600mg from day 6 onward
combined with standard-dose BTK inhibitors (Ibrutinib 420mg qd, Zanubrutinib 160mg bid, or Orelabrutinib 150mg qd) as previously used by patients.
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 79 Years
Inclusion criteria
Inclusion criteria: 1.Diagnosis of CLL, confirmed by histopathology and/or flow cytometry according to the 2016 WHO classification of lymphoid neoplasms or meeting the iwCLL 2018 criteria. 2.Prior BTKi therapy (including Ibrutinib, Zanubrutinib, or Orelabrutinib) for over 1 year, with a achieved response of at least Partial Response (PR), and positive minimal residual disease (MRD) in peripheral blood (PB). 3.Age >= 18 years and = 1.0 × 10?/LPlatelet (PLT) count >= 50 × 10?/L; 6.Essentially normal liver, renal, pulmonary, and cardiac function; 7.The patient or their legally authorized representative must provide written informed consent before any study-specific procedures are performed;
Exclusion criteria
Exclusion criteria: 1.Presence of uncontrolled comorbidities, such as cardiovascular or cerebrovascular diseases, coagulopathies, connective tissue diseases, or severe active infections. 2.Any other concurrent and uncontrolled medical condition that, in the investigator's judgment, would compromise the patient's participation in the study. 3.Patients with psychiatric disorders or other known or suspected conditions that may lead to inadequate compliance with the study protocol. 4.Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MRD negative rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Safety indicators (including: Common adverse reactions of risatokra: neutropenia, thrombocytopenia, anemia, decreased white blood cell count, diarrhea, hyperuricemia, hypokalemia, hyperphosphatemia and hypocalcemia;) Common adverse reactions of BTKi: bleeding, infection, cytopenia, hypertension, arrhythmia, interstitial lung disease, secondary malignant tumors, tumor lysis syndrome, hepatitis B virus reactivation; TLS incidence rate Serious Adverse Events (SAE) The event that led to the detachme; | — |
Countries
China
Contacts
Public ContactShen Kai
West China Hospital of Sichuan University
Outcome results
None listed