Suspended

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-

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What is being tested

Zebutinib&BR or Zebutinib&FCR

Drug
Who is being recruted

Chronic Disease+13

+ Hematologic Diseases

+ Hemic and Lymphatic Diseases

Over 18 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: September 2021
See protocol details

Summary

Principal SponsorNanfang Hospital, Southern Medical University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2021

Actual date on which the first participant was enrolled.

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

Official TitleA 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-
NCT04980859
Principal SponsorNanfang Hospital, Southern Medical University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

45 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Chronic DiseaseHematologic DiseasesHemic and Lymphatic DiseasesImmune System DiseasesImmunoproliferative DisordersLeukemiaLeukemia, LymphoidLymphatic DiseasesLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic TypePathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, B-CellLeukemia, Lymphocytic, Chronic, B-CellDisease Attributes

Criteria

4 inclusion criteria required to participate
CLL patients with indications for treatment according to iwCLL;
CT/MRI shows measurable lesions;
ECOG score is 0-2;
No pregnancy plans during treatment
9 exclusion criteria prevent from participating
Have previously received treatments for chronic lymphocytic leukemia;
Received steroids within 7 days before starting treatment;
Richter transformation;
17p-/TP53 amplification ≥20% (FISH);
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has no location dataSave this study to your profile to know when the location data is available.
SuspendedNo study centers