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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04436107
Recruitment Status : Recruiting
First Posted : June 17, 2020
Last Update Posted : August 19, 2022
Sponsor:
Information provided by (Responsible Party):
BeiGene

Study Description
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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
Relapsed/Refractory Diffuse Large B-Cell Lymphoma Drug: Zanubrutinib Drug: Lenalidomide Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 11, 2020
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : January 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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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 Name: 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 Name: BGB-3111

Drug: Lenalidomide
Administered as specified in the treatment arm


Outcome Measures
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Primary Outcome Measures :
  1. Part 1: Number of Participants Experiencing Adverse Events (AEs) [ Time Frame: Up to 48 months ]
  2. Part 1: Number of Participants Experiencing Severe Adverse Events (SAEs) [ Time Frame: Up to 48 months ]
  3. Part 2: Overall Response Rate (ORR) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: Cycle 1 Day 1 (C1D1) and C1D21 up to 8 hours post-dose ]
  3. Maximum Concentration (Cmax) [ Time Frame: C1D1 and C1D21 up to 8 hours post-dose ]
  4. Time to reach maximum plasma concentration (Tmax) [ Time Frame: C1D1 and C1D21 up to 8 hours post-dose ]
  5. Apparent Clearance (CL/F) [ Time Frame: C1D1 and C1D21 up to 8 hours post-dose ]
  6. Receptor Occupancy (Ro) [ Time Frame: C1D1 and C1D21 up to 8 hours post-dose ]
  7. Complete Response Rate (CRR) [ Time Frame: Up to 48 months ]
  8. Time to Response (TTR) [ Time Frame: Up to 48 months ]
  9. Progression-Free Survival (PFS) [ Time Frame: Up to 48 months ]
  10. Duration of Response (DOR) [ Time Frame: Up to 48 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04436107


Contacts
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Contact: BeiGene 1-877-828-5568 clinicaltrials@beigene.com

Locations
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China, Beijing
Beijing Friendship Hospital, Capital Medical University Recruiting
Beijing, Beijing, China
China, Henan
Henan Cancer Hospital Recruiting
Zhengzhou, Henan, China, 450008
China, Hubei
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology Recruiting
Wuhan, Hubei, China
China, Jilin
Jilin Cancer Hospital Recruiting
Changchun, Jilin, China, 130021
China, Sichuan
West China Hospital · Sichuan University Recruiting
Chengdu, Sichuan, China, 610041
China, Zhejiang
Zhejiang Cancer Hospital Recruiting
Hangzhou, Zhejiang, China
China
Sun Yat-sen University Cancer Center Recruiting
Guangzhou, China, 510060
Fudan University Shanghai Cancer Center Recruiting
Shanghai, China, 200032
Shanghai East Hospital Recruiting
Shanghai, China, 200120
Tianjin Medical University Cancer Institute and Hospital Recruiting
Tianjin, China, 300060
Sponsors and Collaborators
BeiGene
Investigators
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Study Director: Hui Yao, MD BeiGene
More Information
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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT04436107    
Other Study ID Numbers: BGB-3111-110
First Posted: June 17, 2020    Key Record Dates
Last Update Posted: August 19, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Lenalidomide
 Zanubrutinib
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action