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Zanubrutinib Combined With R-CHOP Regimen in the Treatment of Newly Diagnosed DLBCL With High-risk Factors

Primary Purpose

Diffuse Large B Cell Lymphoma

Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Zanubrutinib
Rituximab
Cyclophosphamide
Epirubicin
Vincristine
Prednisone
Sponsored by
Liaoning Tumor Hospital & Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diffuse Large B Cell Lymphoma

Eligibility Criteria

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

Inclusion Criteria: Histologically confirmed DLBCL patients have one of the following risk factors(including but not limited to double expression, extranodal involvement, high ki67, bulky); Age ≥ 18 years old; At least one measurable lesion (defined as lymph node lesion ≥15mm, extra-segmental lesions ≥ 10mm); ECOG performance status 0-2; Functions of major organs meet the following conditions: Echocardiography left ventricular ejection fraction ≥50%; Creatinine clearance ≥30 ml/min; ALT and AST≤3 times the normal range; Hematopoietic function should meet the following conditions: Platelet count ≥50×109/L; Hemoglobin ≥ 8.0g /dL; Absolute count of neutrophil (ANC)≥1.0×109/L; Expected survival of ≧3 months Exclusion Criteria: Major surgery within 4 weeks before treatment; Severe organ dysfunction(including but not limited to complications of uncontrolled cardiovascular diseases, blood clotting disorders, connective tissue diseases, serious infectious diseases and other diseases); Patients who cannot cooperate with treatment or follow-up on time. Pregnant or lactating females; any uncontrolled active systemic infection requiring intravenous (IV) antibiotics; There was a history of other active malignant diseases within the 2 years prior to study entry, except for: (1) adequately treated cervical carcinoma in situ; (2) local skin basal cell carcinoma or squamous cell carcinoma; (3) previous malignant disease that is under control and has undergone local radical treatment (surgical or other forms). History of severe hemorrhagic disorders, such as hemophilia A, hemophilia B, von Willebrand's disease, or spontaneous bleeding requiring blood transfusion or other medical intervention Human immunodeficiency virus (HIV) infection or the following serological status reflecting the presence of active hepatitis B or C virus infection: a. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) are present. Patients who are HBCAB-positive, HBsAg negative, have no hepatitis b virus (HBV) DNA (< 20 IU/mL), and agree to be monitored for HBV virus reactivation can be enrolled. Antibodies to the hepatitis C virus (HCV) are present. HCV antibody-positive patients with no HCV RNA detected could be included in the group. The presence of any life-threatening disease, medical condition, or organ system dysfunction that the investigator believes may affect the subject's safety or pose a risk to the study. The researchers think it is not suitable to participate in this experiment.

Sites / Locations

  • Xing Xiaojing

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Zanubrutinib + R-CHOP

Arm Description

Outcomes

Primary Outcome Measures

Complete response rate(CRR)

Secondary Outcome Measures

Overall response rate (ORR)
Progression-free Survival(PFS)
Overall survival (OS)
Duration of Response
Incidence of adverse event
Assessment of the correlation between MYD88、CD79B、NOTCH1、BCL6、NOTCH2 or other gene abnormality and efficacy.

Full Information

First Posted
March 20, 2023
Last Updated
July 26, 2023
Sponsor
Liaoning Tumor Hospital & Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05887726
Brief Title
Zanubrutinib Combined With R-CHOP Regimen in the Treatment of Newly Diagnosed DLBCL With High-risk Factors
Official Title
A Single-arm, Prospective Clinical Study on the Antitumor Activity and Safety of Zanubrutinib Combined With R-CHOP Regimen in the Treatment of Newly Diagnosed DLBCL With High-risk Factors
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2023 (Anticipated)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
August 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Liaoning Tumor Hospital & Institute

4. Oversight

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

5. Study Description

Brief Summary
This study is a prospective, open-label, single-arm phase II clinical study to evaluate the safety and efficacy of zanubrutinib plus R-CHOP (ZR-CHOP) as the first-line therapy for newly diagnosed diffuse large B-cell lymphoma patients with high-risk factors.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Large B Cell Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Zanubrutinib + R-CHOP
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Zanubrutinib
Intervention Description
Zanubrutinib 160mg bid p.o d0-d20(21-day cycles)
Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Description
Rituximab 375 mg/m2 i.v d0(21-day cycles)
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
Cyclophosphamide 750 mg/m2 i.v d1(21-day cycles)
Intervention Type
Drug
Intervention Name(s)
Epirubicin
Intervention Description
Epirubicin 75 mg/m2 i.v d1 or liposome adriamycin 35mg/m2 i.v d1(21-day cycles)
Intervention Type
Drug
Intervention Name(s)
Vincristine
Intervention Description
Vincristine 1.4 mg/m2 i.v d1 (2 mg max) (21-day cycles)
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
Prednisone 100 mg p.o d1-d5 (21-day cycles)
Primary Outcome Measure Information:
Title
Complete response rate(CRR)
Time Frame
Up to approximately 2.5 years
Secondary Outcome Measure Information:
Title
Overall response rate (ORR)
Time Frame
Up to approximately 2.5 years
Title
Progression-free Survival(PFS)
Time Frame
Up to approximately 2.5 years
Title
Overall survival (OS)
Time Frame
Up to approximately 2.5 years
Title
Duration of Response
Time Frame
At 2 years
Title
Incidence of adverse event
Time Frame
At 2 years
Title
Assessment of the correlation between MYD88、CD79B、NOTCH1、BCL6、NOTCH2 or other gene abnormality and efficacy.
Time Frame
At 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed DLBCL patients have one of the following risk factors(including but not limited to double expression, extranodal involvement, high ki67, bulky); Age ≥ 18 years old; At least one measurable lesion (defined as lymph node lesion ≥15mm, extra-segmental lesions ≥ 10mm); ECOG performance status 0-2; Functions of major organs meet the following conditions: Echocardiography left ventricular ejection fraction ≥50%; Creatinine clearance ≥30 ml/min; ALT and AST≤3 times the normal range; Hematopoietic function should meet the following conditions: Platelet count ≥50×109/L; Hemoglobin ≥ 8.0g /dL; Absolute count of neutrophil (ANC)≥1.0×109/L; Expected survival of ≧3 months Exclusion Criteria: Major surgery within 4 weeks before treatment; Severe organ dysfunction(including but not limited to complications of uncontrolled cardiovascular diseases, blood clotting disorders, connective tissue diseases, serious infectious diseases and other diseases); Patients who cannot cooperate with treatment or follow-up on time. Pregnant or lactating females; any uncontrolled active systemic infection requiring intravenous (IV) antibiotics; There was a history of other active malignant diseases within the 2 years prior to study entry, except for: (1) adequately treated cervical carcinoma in situ; (2) local skin basal cell carcinoma or squamous cell carcinoma; (3) previous malignant disease that is under control and has undergone local radical treatment (surgical or other forms). History of severe hemorrhagic disorders, such as hemophilia A, hemophilia B, von Willebrand's disease, or spontaneous bleeding requiring blood transfusion or other medical intervention Human immunodeficiency virus (HIV) infection or the following serological status reflecting the presence of active hepatitis B or C virus infection: a. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) are present. Patients who are HBCAB-positive, HBsAg negative, have no hepatitis b virus (HBV) DNA (< 20 IU/mL), and agree to be monitored for HBV virus reactivation can be enrolled. Antibodies to the hepatitis C virus (HCV) are present. HCV antibody-positive patients with no HCV RNA detected could be included in the group. The presence of any life-threatening disease, medical condition, or organ system dysfunction that the investigator believes may affect the subject's safety or pose a risk to the study. The researchers think it is not suitable to participate in this experiment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaojing Xing, Ph.D
Phone
18900917660
Email
13940066477@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaojing Xing, Ph.D
Organizational Affiliation
Liaoning Tumor Hospital & Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xing Xiaojing
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Zanubrutinib Combined With R-CHOP Regimen in the Treatment of Newly Diagnosed DLBCL With High-risk Factors

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