Zanubrutinib, in Combination With Lenalidomide, With or Without Rituximab in Participants With Relapsed/Refractory Diffuse Large B-Cell Lymphoma
- Conditions
- Relapsed/Refractory Diffuse Large B-Cell Lymphoma
- Interventions
- Registration Number
- NCT04436107
- Lead Sponsor
- BeiGene
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 66
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 2 : Zanubrutinib+Lenalidomide Zanubrutinib 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 Part 1 : Zanubrutinib + Lenalidomide Zanubrutinib Zanubrutinib for up to 48 months Lenalidomide on Days 1 - 21 of each 28-Day cycle for up to 48 months Part 1 : Zanubrutinib + Lenalidomide Lenalidomide Zanubrutinib for up to 48 months Lenalidomide on Days 1 - 21 of each 28-Day cycle for up to 48 months Part 2 : Zanubrutinib+Lenalidomide 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
- Primary Outcome Measures
Name Time Method Part 1: Number of Participants Experiencing Severe Adverse Events (SAEs) Up to 48 months Part 1: Number of Participants Experiencing Adverse Events (AEs) Up to 48 months 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
Name Time Method Time to Response (TTR) Up to 48 months 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)
Maximum Concentration (Cmax) C1D1 and C1D21 up to 8 hours post-dose Progression-Free Survival (PFS) Up to 48 months Time to reach maximum plasma concentration (Tmax) C1D1 and C1D21 up to 8 hours post-dose Apparent Clearance (CL/F) C1D1 and C1D21 up to 8 hours post-dose Complete Response Rate (CRR) Up to 48 months Duration of Response (DOR) Up to 48 months 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 Receptor Occupancy (Ro) C1D1 and C1D21 up to 8 hours post-dose
Trial Locations
- Locations (10)
Beijing Friendship Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Sun Yat Sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China
Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
Jilin Cancer Hospital
🇨🇳Changchun, Jilin, China
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, Shanghai, China
Shanghai East Hospital
🇨🇳Shanghai, Shanghai, China
West China Hospital, Sichuan University
🇨🇳Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute and Hospital
🇨🇳Tianjin, Tianjin, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China