Zebutinib Combined With Immunochemotherapy in the Treat of Newly Treated CLL Patients Without 17p-/TP53 Mutation
A Phase III, Single-arm Clinical Trial of Zebutinib Combined With Immunochemotherapy With Limited Course of Treatment for Newly Treated Chronic Lymphocytic Leukemia Patients Without 17p-
1 other identifier
interventional
45
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Sep 2021
Typical duration for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 9, 2021
CompletedFirst Posted
Study publicly available on registry
July 28, 2021
CompletedStudy Start
First participant enrolled
September 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2025
CompletedJuly 28, 2021
July 1, 2021
4 years
July 9, 2021
July 27, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
MRD conversion rate (minimal residual disease conversion rate)
minimal residual disease conversion rate
30 days
Secondary Outcomes (2)
OS (overall survival)
3 years
PFS (progression-free survival)
3 years
Study Arms (1)
Zebutinib Combined With CIT arm
EXPERIMENTALZebutinib Combined With FCR( under 60 years of age) or BR (over 60 years of age )
Interventions
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.
Eligibility Criteria
You may qualify if:
- CLL patients with indications for treatment according to iwCLL;
- CT/MRI shows measurable lesions;
- ECOG score is 0-2;
- No pregnancy plans during treatment
You may not qualify if:
- Richter transformation;
- p-/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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 9, 2021
First Posted
July 28, 2021
Study Start
September 1, 2021
Primary Completion
September 1, 2025
Study Completion
September 1, 2025
Last Updated
July 28, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share