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NCT04980859 Clinical Trial

Zebutinib Combined With Immunochemotherapy in the Treat of Newly Treated CLL Patients Without 17p-/TP53 Mutation

Chronic Lymphocytic Leukemia Clinical Trial

Official title:
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-

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04980859
Other study ID # CLL-NFH-202103
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date September 1, 2021
Est. completion date September 1, 2025

Study information
Verified date July 2021
Source Nanfang Hospital of Southern Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To investigate limited course of treatment of Zebutinib combined with immunochemotherapy for patients with newly treated chronic lymphocytic leukemia without 17p-/TP53 mutation

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 45
Est. completion date September 1, 2025
Est. primary completion date September 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Zebutinib&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.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Nanfang Hospital of Southern Medical University

Outcome
Type Measure Description Time frame Safety issue
Primary MRD conversion rate (minimal residual disease conversion rate) minimal residual disease conversion rate 30 days
Secondary OS (overall survival) overall survival 3 years
Secondary PFS (progression-free survival) progression-free survival 3 years
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