Back to resultsZanubrutinib, in Combination With Lenalidomide, With or Without Rituximab in Participants With Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Primary Purpose
Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Zanubrutinib
Lenalidomide
Sponsored by
About this trial
This is an interventional treatment trial for Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Eligibility Criteria
Key Inclusion Criteria:
- Histologically confirmed DLBCL, all participants must provide sufficient archival or fresh tumor tissue samples for evaluation by immunohistochemistry (IHC) and Gene Expression Profiling (GEP).
- 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.
- Participants who have not received high dose therapy/stem cell transplantation (HDT/SCT) must be ineligible for HDT/SCT.
- 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.
- 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:
- Current or history of central nervous system (CNS) lymphoma.
- Histologically transformed lymphoma.
- History of allogeneic stem-cell transplantation.
- Prior exposure to a BTK inhibitor.
- Prior exposure to lenalidomide or thalidomide.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Sites / Locations
- Beijing Friendship Hospital, Capital Medical UniversityRecruiting
- Henan Cancer HospitalRecruiting
- Union Hospital of Tongji Medical College, Huazhong University of Science and TechnologyRecruiting
- Jilin Cancer HospitalRecruiting
- West China Hospital · Sichuan UniversityRecruiting
- Zhejiang Cancer HospitalRecruiting
- Sun Yat-sen University Cancer CenterRecruiting
- Fudan University Shanghai Cancer CenterRecruiting
- Shanghai East HospitalRecruiting
- Tianjin Medical University Cancer Institute and HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Part 1 : Zanubrutinib + Lenalidomide
Part 2 : Zanubrutinib+Lenalidomide
Arm Description
Zanubrutinib for up to 48 months Lenalidomide on Days 1 - 21 of each 28-Day cycle for up to 48 months
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
Outcomes
Primary Outcome Measures
Part 1: Number of Participants Experiencing Adverse Events (AEs)
Part 1: Number of Participants Experiencing Severe Adverse Events (SAEs)
Part 2: Overall Response Rate (ORR)
The proportion of participants who achieve either a partial response (PR) or complete response (CR)
Secondary Outcome Measures
Part 1: Overall Response Rate (ORR)
The proportion of participants who achieve either a partial response (PR) or complete response (CR)
Area Under the Curve from Zero to Last Measurable Concentration (AUC0-t)
Maximum Concentration (Cmax)
Time to reach maximum plasma concentration (Tmax)
Apparent Clearance (CL/F)
Receptor Occupancy (Ro)
Complete Response Rate (CRR)
Time to Response (TTR)
Progression-Free Survival (PFS)
Duration of Response (DOR)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04436107
Brief Title
Zanubrutinib, in Combination With Lenalidomide, With or Without Rituximab in Participants With Relapsed/Refractory Diffuse Large B-Cell Lymphoma
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 11, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BeiGene
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed/Refractory Diffuse Large B-Cell Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
67 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Part 1 : Zanubrutinib + Lenalidomide
Arm Type
Experimental
Arm Description
Zanubrutinib for up to 48 months
Lenalidomide on Days 1 - 21 of each 28-Day cycle for up to 48 months
Arm Title
Part 2 : Zanubrutinib+Lenalidomide
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Zanubrutinib
Other Intervention Name(s)
BGB-3111
Intervention Description
160 mg administered orally twice daily (BID)
Intervention Type
Drug
Intervention Name(s)
Lenalidomide
Intervention Description
Administered as specified in the treatment arm
Primary Outcome Measure Information:
Title
Part 1: Number of Participants Experiencing Adverse Events (AEs)
Time Frame
Up to 48 months
Title
Part 1: Number of Participants Experiencing Severe Adverse Events (SAEs)
Time Frame
Up to 48 months
Title
Part 2: Overall Response Rate (ORR)
Description
The proportion of participants who achieve either a partial response (PR) or complete response (CR)
Time Frame
Up to 48 months
Secondary Outcome Measure Information:
Title
Part 1: Overall Response Rate (ORR)
Description
The proportion of participants who achieve either a partial response (PR) or complete response (CR)
Time Frame
Up to 48 months
Title
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
Title
Maximum Concentration (Cmax)
Time Frame
C1D1 and C1D21 up to 8 hours post-dose
Title
Time to reach maximum plasma concentration (Tmax)
Time Frame
C1D1 and C1D21 up to 8 hours post-dose
Title
Apparent Clearance (CL/F)
Time Frame
C1D1 and C1D21 up to 8 hours post-dose
Title
Receptor Occupancy (Ro)
Time Frame
C1D1 and C1D21 up to 8 hours post-dose
Title
Complete Response Rate (CRR)
Time Frame
Up to 48 months
Title
Time to Response (TTR)
Time Frame
Up to 48 months
Title
Progression-Free Survival (PFS)
Time Frame
Up to 48 months
Title
Duration of Response (DOR)
Time Frame
Up to 48 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Histologically confirmed DLBCL, all participants must provide sufficient archival or fresh tumor tissue samples for evaluation by immunohistochemistry (IHC) and Gene Expression Profiling (GEP).
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.
Participants who have not received high dose therapy/stem cell transplantation (HDT/SCT) must be ineligible for HDT/SCT.
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.
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:
Current or history of central nervous system (CNS) lymphoma.
Histologically transformed lymphoma.
History of allogeneic stem-cell transplantation.
Prior exposure to a BTK inhibitor.
Prior exposure to lenalidomide or thalidomide.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BeiGene
Phone
1-877-828-5568
Email
clinicaltrials@beigene.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hui Yao, MD
Organizational Affiliation
BeiGene
Official's Role
Study Director
Facility Information:
Facility Name
Beijing Friendship Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Individual Site Status
Recruiting
Facility Name
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
Country
China
Individual Site Status
Recruiting
Facility Name
Jilin Cancer Hospital
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Individual Site Status
Recruiting
Facility Name
West China Hospital · Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Name
Shanghai East Hospital
City
Shanghai
ZIP/Postal Code
200120
Country
China
Individual Site Status
Recruiting
Facility Name
Tianjin Medical University Cancer Institute and Hospital
City
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Zanubrutinib, in Combination With Lenalidomide, With or Without Rituximab in Participants With Relapsed/Refractory Diffuse Large B-Cell Lymphoma
We'll reach out to this number within 24 hrs