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

NCT ID: NCT04980859

Last Updated: 2021-07-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2025-09-01

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

Conditions

Chronic Lymphocytic Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Zebutinib Combined With CIT arm

Zebutinib Combined With FCR( under 60 years of age) or BR (over 60 years of age )

Group Type: EXPERIMENTAL

Zebutinib&BR or Zebutinib&FCR

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role: lead

Responsible Party

Ru Feng

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

CLL-NFH-202103

Identifier Type: -

Identifier Source: org_study_id