NCT04980859

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-

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Nanfang Hospital, Southern Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-09-01
• Primary completion: 2025-09-01
• Completion: 2025-09-01
• First posted: 2021-07-28
• Last updated: 2021-07-28