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

Nanfang Hospital, Southern Medical University

Status and phase: Not yet enrolling; Phase 3

Conditions: Chronic Lymphocytic Leukemia

Treatments: Drug: Zebutinib&BR or Zebutinib&FCR

Study type: Interventional

Funder types: Other

Identifiers

NCT04980859

CLL-NFH-202103

Details and patient eligibility

About

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

Enrollment: 45 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

Zebutinib Combined With CIT arm

Experimental group

Description:

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

Treatment:

Drug: Zebutinib&BR or Zebutinib&FCR