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Zanubrutinib, in Combination With Lenalidomide, With or Without Rituximab in Participants With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Sponsor
BeiGene (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04436107
Collaborator
(none)
67
Enrollment
10
Locations
2
Arms
40.6
Anticipated Duration (Months)
6.7
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of this study is to determine the maximum tolerated doses (MTD) and the recommended Phase 2 dose (RP2D), and safety and tolerability of zanubrutinib in combination with lenalidomide in participants with R/R DLBCL by dose escalating lenalidomide

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
67 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1, Open Label, Multiple Dose, Dose Escalation and Expansion Study of Bruton Tyrosine Kinase (BTK) Inhibitor, Zanubrutinib, in Combination With Lenalidomide, With or Without Rituximab in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Actual Study Start Date :
Sep 11, 2020
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Jan 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Part 1 : Zanubrutinib + Lenalidomide

Zanubrutinib for up to 48 months Lenalidomide on Days 1 - 21 of each 28-Day cycle for up to 48 months

Drug: Zanubrutinib
160 mg administered orally twice daily (BID)
Other Names:
  • BGB-3111

    • Drug: Lenalidomide
    Administered as specified in the treatment arm
    Experimental: Part 2 : Zanubrutinib+Lenalidomide

    Zanubrutinib for up to 48 months Lenalidomide at the RP2D dose determined from Part 1 administered on Days 1 - 21 of each 28-Day cycle for up to 48 months

    Drug: Zanubrutinib
    160 mg administered orally twice daily (BID)
    Other Names:
  • BGB-3111

    • Drug: Lenalidomide
    Administered as specified in the treatment arm

    Outcome Measures

    Primary Outcome Measures

    1. Part 1: Number of Participants Experiencing Adverse Events (AEs) [Up to 48 months]

    2. Part 1: Number of Participants Experiencing Severe Adverse Events (SAEs) [Up to 48 months]

    3. Part 2: Overall Response Rate (ORR) [Up to 48 months]

      The proportion of participants who achieve either a partial response (PR) or complete response (CR)

    Secondary Outcome Measures

    1. Part 1: Overall Response Rate (ORR) [Up to 48 months]

      The proportion of participants who achieve either a partial response (PR) or complete response (CR)

    2. Area Under the Curve from Zero to Last Measurable Concentration (AUC0-t) [Cycle 1 Day 1 (C1D1) and C1D21 up to 8 hours post-dose]

    3. Maximum Concentration (Cmax) [C1D1 and C1D21 up to 8 hours post-dose]

    4. Time to reach maximum plasma concentration (Tmax) [C1D1 and C1D21 up to 8 hours post-dose]

    5. Apparent Clearance (CL/F) [C1D1 and C1D21 up to 8 hours post-dose]

    6. Receptor Occupancy (Ro) [C1D1 and C1D21 up to 8 hours post-dose]

    7. Complete Response Rate (CRR) [Up to 48 months]

    8. Time to Response (TTR) [Up to 48 months]

    9. Progression-Free Survival (PFS) [Up to 48 months]

    10. Duration of Response (DOR) [Up to 48 months]

    Eligibility Criteria

    Criteria

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

    1. Histologically confirmed DLBCL, all participants must provide sufficient archival or fresh tumor tissue samples for evaluation by immunohistochemistry (IHC) and Gene Expression Profiling (GEP).

    2. Relapsed or refractory disease, defined as either: 1) progression of disease after having achieved disease remission (complete response [CR] or partial response [PR]) , or 2) stable disease (SD), or progressive disease (PD) at completion of the treatment regimen preceding entry to the study.

    3. Participants who have not received high dose therapy/stem cell transplantation (HDT/SCT) must be ineligible for HDT/SCT.

    4. Measurable disease as defined by at least 1 lymph node >1.5 cm in longest diameter, or at least 1 extra-nodal lesion >1.0 cm in longest diameter, and measurable in 2 perpendicular dimensions.

    5. Received an appropriate first-line therapy for DLBCL,defined as an anti CD20 antibody and an appropriate anthracycline-based combination therapy for at least 2 cycles, unless the patient is intolerant or had disease progression before Cycle 2..

    Key Exclusion Criteria:

    1. Current or history of central nervous system (CNS) lymphoma.

    2. Histologically transformed lymphoma.

    3. History of allogeneic stem-cell transplantation.

    4. Prior exposure to a BTK inhibitor.

    5. Prior exposure to lenalidomide or thalidomide.

    NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beijing Friendship Hospital, Capital Medical University Beijing Beijing China
    2 Henan Cancer Hospital Zhengzhou Henan China 450008
    3 Union Hospital of Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei China
    4 Jilin Cancer Hospital Changchun Jilin China 130021
    5 West China Hospital ยท Sichuan University Chengdu Sichuan China 610041
    6 Zhejiang Cancer Hospital Hangzhou Zhejiang China
    7 Sun Yat-sen University Cancer Center Guangzhou China 510060
    8 Fudan University Shanghai Cancer Center Shanghai China 200032
    9 Shanghai East Hospital Shanghai China 200120
    10 Tianjin Medical University Cancer Institute and Hospital Tianjin China 300060

    Sponsors and Collaborators

    • BeiGene

    Investigators

    • Study Director: Hui Yao, MD, BeiGene

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    BeiGene
    ClinicalTrials.gov Identifier:
    NCT04436107
    Other Study ID Numbers:
    • BGB-3111-110
    First Posted:
    Jun 17, 2020
    Last Update Posted:
    Aug 19, 2022
    Last Verified:
    Aug 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
    Lenalidomide
    Zanubrutinib

    Study Results

    No Results Posted as of Aug 19, 2022