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
• Status: Not yet recruiting
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

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