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

Primary Purpose

Chronic Lymphocytic Leukemia

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Zebutinib&BR or Zebutinib&FCR
Sponsored by
Nanfang Hospital, Southern Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Lymphocytic Leukemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Zebutinib Combined With CIT arm

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    MRD conversion rate (minimal residual disease conversion rate)
    minimal residual disease conversion rate

    Secondary Outcome Measures

    OS (overall survival)
    overall survival
    PFS (progression-free survival)
    progression-free survival

    Full Information

    First Posted
    July 9, 2021
    Last Updated
    July 27, 2021
    Sponsor
    Nanfang Hospital, Southern Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04980859
    Brief Title
    Zebutinib Combined With Immunochemotherapy in the Treat of Newly Treated CLL Patients Without 17p-/TP53 Mutation
    Official Title
    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-
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2021 (Anticipated)
    Primary Completion Date
    September 1, 2025 (Anticipated)
    Study Completion Date
    September 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Nanfang Hospital, Southern Medical University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Lymphocytic Leukemia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    45 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Zebutinib Combined With CIT arm
    Arm Type
    Experimental
    Arm Description
    Zebutinib Combined With FCR( under 60 years of age) or BR (over 60 years of age )
    Intervention Type
    Drug
    Intervention Name(s)
    Zebutinib&BR or Zebutinib&FCR
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    MRD conversion rate (minimal residual disease conversion rate)
    Description
    minimal residual disease conversion rate
    Time Frame
    30 days
    Secondary Outcome Measure Information:
    Title
    OS (overall survival)
    Description
    overall survival
    Time Frame
    3 years
    Title
    PFS (progression-free survival)
    Description
    progression-free survival
    Time Frame
    3 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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