Chronic Lymphocytic Leukemia
Conditions
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
Interventions
DRUGZebutinib&BR or Zebutinib&FCR
Introduction period: Zebutinib 160 mg bid oral treatment for 3 months;Joint stage :6 sessions of Zebutinib FCR( under 60 years of age,Fludarabine 25 mg/m² Q3W, Cyclophosphamide 250 mg/m² Q3W,Rituximab 375 mg/m² Q3W) or BR (over 60 years of age, )(28 days and 1 cycle);Maintenance treatment: after the end of the combined phase, continue the treatment of zebutinib.
Sponsors
Nanfang Hospital, Southern Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MRD conversion rate (minimal residual disease conversion rate) | 30 days | minimal residual disease conversion rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OS (overall survival) | 3 years | overall survival |
| PFS (progression-free survival) | 3 years | progression-free survival |
Outcome results
None listed