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

NCT04980859 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2021-07-28

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Nanfang Hospital, Southern Medical University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2025-09-01
Completion
2025-09-01

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04980859 on ClinicalTrials.gov