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Treatment of CD79B Mutant Relapsed/Refractory Diffuse Large B-Cell Lymphoma With Bruton Tyrosine Kinase Inhibitor Zanubrutinib

Sponsor
BeiGene (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05068440
Collaborator
(none)
66
Enrollment
22
Locations
1
Arm
28.6
Anticipated Duration (Months)
3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Study consists of a single arm to explore the efficacy and safery of zanubrutinib in patients with CD79B mutant Relapsed/Refractory Diffuse Large B-Cell Lymphoma.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
66 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2, Single-Arm, Open-Label, Multicenter Study of the Bruton Tyrosine Kinase Inhibitor Zanubrutinib in Patients With CD79B Mutant Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Actual Study Start Date :
Aug 11, 2021
Anticipated Primary Completion Date :
Dec 30, 2022
Anticipated Study Completion Date :
Dec 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Zanubrutinib

administered orally

Drug: Zanubrutinib
administered orally as capsules
Other Names:
  • BGB-3111

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Overall response rate (ORR) [approximately 2 years]

      Defined as the proportion of patients who achieved a stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) by investigator assessment according to the Lugano classification for Non-Hodgkin's Lymphoma (NHL).

    Secondary Outcome Measures

    1. Overall response rate (ORR) [approximately 2 years]

      Defined as the proportion of patients who achieved a stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) by Independent Review Committee assessment according to the Lugano classification for Non-Hodgkin's Lymphoma (NHL).

    2. Complete response rate (CRR) [approximately 2 years]

      defined as the proportion of patients with a documented CR or sCR determined by the Independent Review Committee and by investigator assessment

    3. Duration of response (DOR) [approximately 2 years]

      DOR is defined as the time from the date of the first documented response (PR or better) after treatment initiation until the date of first documented disease progression or death, whichever occurs first. Determined by the Independent Review Committee and by investigator assessment

    4. Progression-free survival (PFS) [approximately 2 years]

      PFS is defined as time from start of treatment to the first documentation of disease progression or death, whichever occurs first as determined by the Independent Review Committee and by investigator assessment

    5. Time to response (TTR) [approximately 2 years]

      TTR is defined as the time from start of treatment to first documentation of response of Partial Response (PR) or better as determined by the Independent Review Committee and by investigator assessment

    6. Overall survival (OS) [approximately 2 years]

      OS defined as the time from start of treatment to the date of death due to any cause

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Histologically confirmed DLBCL based on the World Health Organization (WHO) 2008 classification of tumors of hematopoietic and lymphoid tissue.

    2. Positive CD79B mutation confirmed by the central laboratory.

    3. Previously received at least 1 line of adequate systemic anti-DLBCL therapy, defined as an anti-CD20 antibody-based chemoimmunotherapy for at least 2 consecutive cycles, unless patients had disease progression before Cycle 2

    4. Relapsed or refractory (R/R) disease before study entry, defined as either

    5. Recurrent disease after having achieved disease remission (CR or partial response [PR]) at the completion of the latest treatment regimen.

    6. Stable disease or PD at the completion of the latest treatment regimen

    7. Ineligible for high dose therapy/stem cell transplantation, which is defined as meeting any of the following criteria:

    8. Significant organ dysfunction (eg, left ventricular ejection fraction < 50% by echocardiogram or multiple gated acquisition scan [MUGA], diffuse lung capacity for carbon monoxide < 60% predicted by pulmonary function test, creatinine clearance < 70 mL/min shown by nuclear medicine scan or 24-hour urine collection) or comorbidities precluding the use of high dose therapy/stem cell transplantation on the basis of unacceptable risk of treatment-related morbidity

    9. Failure to achieve CR or PR with salvage therapy.

    10. Failure to collect stem cells or unable to perform stem cell collection as assessed by the investigator.

    Exclusion Criteria:

    1. Patients who have NHL other than classical histology DLBCL, eg, patients with DLBCL transformed from indolent lymphomas, primary mediastinal (thymic) large B-cell lymphoma, primary cutaneous DLBCL, primary effusion lymphoma, and central nervous system (CNS) lymphoma.

    2. History of allogeneic stem cell transplantation or chimeric antigen receptor (CAR) T-cell therapy.

    3. Prior exposure to a BTK inhibitor.

    4. Receipt of the following treatment at the time indicated before the first dose of study drug:

    5. Corticosteroids given with antineoplastic intent more than 7 days, unless it is for control of lymphoma-related symptoms provided it is tapered off within 5 days after initiation of study treatment.

    6. Chemotherapy or radiotherapy within 2 weeks.

    7. Monoclonal antibody within 2 weeks.

    8. Investigational therapy within 2 weeks.

    9. Chinese patent medicine with antineoplastic intent within 2 weeks.

    10. History of other active malignancies within 2 years before study entry, with the exception of (1) adequately treated in-situ carcinoma of the cervix; (2) localized basal cell or squamous cell carcinoma of the skin; (3) previous malignancy confined and treated locally (surgery or other modality) with curative intent. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Anhui Provincial Cancer Hospital Hefei Anhui China 230088
    2 Beijing Friendship Hospital, Capital Medical University Beijing Beijing China
    3 Fujian Cancer Hospital Fuzhou Fujian China 350014
    4 Guangdong Provincial People's Hospital Guangzhou Guangdong China 510080
    5 Sun Yat-Sen University Cancer Center Guangzhou Guangdong China
    6 The first affiliated hospital of Shantou University Shantou Guangdong China
    7 Hainan Cancer Hospital Haikou Hainan China
    8 Harbin Medical University Cancer Hospital - Oncology Haerbin Heilongjiang China 150081
    9 Henan Cancer Hospital Zhengzhou Henan China 450008
    10 Union Hospital of Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei China 430023
    11 Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology Wuhan Hubei China
    12 The Second Xiangya Hospital of Central South University Changsha Hunan China 410011
    13 The First Hospital of Jilin University Changchun Jilin China 130021
    14 Liaoning Cancer Hospital & Institute - Medical Oncology - Oncology Shenyang Liaoning China 110017
    15 Rui Jin Hospital Shanghai Jiao Tong University School of Medicine Shanghai Shanghai China
    16 West China Hospital, Sichuan University Chengdu Sichuan China 610041
    17 Institute of Hematology and Hospital of Blood Disease Tianjin Tianjin China 3100020
    18 The Second Affiliated Hospital of Zhejiang University School of Medicine Hangzhou Zhejiang China 310009
    19 The First Affiliated Hospital of Guangzhou Medical University Guangzhou China 510120
    20 The First Affiliated Hospital of Nanchang University Nanchang China 330006
    21 Taizhou Hospital of Zhejiang Province Taizhou China 317000
    22 The First Affiliated Hospital, Zhejiang University School of Medicine Zhejiang China

    Sponsors and Collaborators

    • BeiGene

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    BeiGene
    ClinicalTrials.gov Identifier:
    NCT05068440
    Other Study ID Numbers:
    • BGB-3111-218
    • CTR20210786
    First Posted:
    Oct 5, 2021
    Last Update Posted:
    Mar 16, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lymphoma
    Lymphoma, B-Cell
    Lymphoma, Large B-Cell, Diffuse
    Zanubrutinib

    Study Results

    No Results Posted as of Mar 16, 2022