Zebutinib Combined With Immunochemotherapy in the Treat of Newly Treated CLL Patients Without 17p-/TP53 Mutation
Phase 3
Not yet recruiting
- Conditions
- Chronic Lymphocytic Leukemia
- Interventions
- Drug: Zebutinib&BR or Zebutinib&FCR
- Registration Number
- NCT04980859
- Lead Sponsor
- Nanfang Hospital, Southern Medical University
- Brief Summary
To investigate limited course of treatment of Zebutinib combined with immunochemotherapy for patients with newly treated chronic lymphocytic leukemia without 17p-/TP53 mutation
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 45
Inclusion Criteria
- CLL patients with indications for treatment according to iwCLL;
- CT/MRI shows measurable lesions;
- ECOG score is 0-2;
- No pregnancy plans during treatment
Exclusion Criteria
- Richter transformation;
- 17p-/TP53 amplification ≥20% (FISH);
- Received steroids within 7 days before starting treatment;
- Have previously received treatments for chronic lymphocytic leukemia;
- Vaccine live attenuated vaccine within 4 weeks of randomization;
- Any life-threatening disease;
- Central nervous system leukemia;
- Apoplexy, history of intracranial hemorrhage;
- HIV or HCV or HBVpositive
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Zebutinib Combined With CIT arm Zebutinib&BR or Zebutinib&FCR Zebutinib Combined With FCR( under 60 years of age) or BR (over 60 years of age )
- Primary Outcome Measures
Name Time Method MRD conversion rate (minimal residual disease conversion rate) 30 days minimal residual disease conversion rate
- Secondary Outcome Measures
Name Time Method PFS (progression-free survival) 3 years progression-free survival
OS (overall survival) 3 years overall survival