B Cell Lymphoma, Mantle Cell Lymphoma
Conditions
Keywords
mantle cell lymphoma, MCL, relapsed/refractory mantle cell lymphoma, sonrotoclax, BGB-11417
Brief summary
The goal of this study is to compare how well sonrotoclax plus zanubrutinib works versus zanubrutinib plus placebo in treating adults with relapsed/refractory (R/R) mantle cell lymphoma (MCL). This study will also look at the safety of sonrotoclax plus zanubrutinib versus zanubrutinib plus placebo.
Detailed description
Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.
Interventions
DRUGSonrotoclax
Administered orally
DRUGZanubrutinib
Administered orally
DRUGPlacebo
Administered orally
Sponsors
BeOne Medicines
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically locally confirmed diagnosis of MCL based on the World Health Organization 2022 classification of Haematolymphoid Tumors (WHO-HAEM5), or based on International Consensus Classification (ICC) * Ability to provide archival or fresh tumor tissue for retrospective central confirmation of MCL diagnosis * Received 1 to 5 prior lines of systemic therapy including an anti-CD20 monoclonal antibody (mAb)-based immunotherapy or chemoimmunotherapy and requiring treatment in the opinion of the investigator * Relapsed or refractory disease after the last line of therapy * Measurable disease defined as ≥ 1 nodal lesion that is \> 1.5 cm in longest diameter, or ≥ 1 extranodal lesion that is \> 1 cm in longest diameter * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2 * Adequate organ function
Exclusion criteria
* Prior therapy with B-cell lymphoma-2 inhibitor (BCL2i) * Prior therapy with BTK degraders * Prior therapy with covalent or non-covalent Bruton tyrosine kinase inhibitor (BTKi) unless the participant was intolerant of non-zanubrutinib covalent or non-covalent BTKi. Participants with refractory disease to BTKi therapy or relapse attributed to failure of BTKi therapy are ineligible. * Prior autologous stem cell transplantation or chimeric antigen receptor T-cell therapy within 3 months before first dose of study drug * Prior allogeneic stem cell transplant within 6 months of the first dose of the study drug * Known central nervous system involvement by lymphoma * Clinically significant cardiovascular disease * History of stroke or intracranial hemorrhage within 6 months before first dose of study drug Note: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) as assessed by Blinded Independent Review Committee (BIRC) | Approximately 41 months | PFS is defined as the time from randomization to the date of progression or death, whichever occurs first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | Approximately 92 months | OS is defined as the time from randomization to the date of death from any cause. |
| PFS as assessed by investigator (INV) | Approximately 58 months | PFS is defined as the time from randomization to the date of progression or death, whichever occurs first. |
| Overall Response Rate (ORR) as assessed by BIRC and by INV | Approximately 58 months | ORR is defined as the percentage of participants who achieved a best overall response of partial response (PR) or complete response (CR), per Lugano 2014 criteria. |
| Duration of Response (DOR) as assessed by BIRC and by INV | Approximately 58 months | DOR is defined as the time from the first qualifying response to the date of progression or death, whichever occurs first. |
| Complete Response Rate (CRR) as assessed by BIRC and by INV | Approximately 58 months | CRR is defined as the percentage of participants who achieved a best overall response of CR. |
| Time to first response as assessed by BIRC and by INV | Approximately 58 months | Time to first response is defined as time from the date of randomization to first response. |
| Time to initiation of new anticancer therapy | Approximately 58 months | Time to initiation of new anticancer therapy is defined as time from the date of randomization to the date of initiation of new anticancer therapy. |
| Health-Related Quality of Life (HRQoL) as Assessed by the European Organisation of Research and Treatment of Cancer-Quality of Life Questionnaire Non-Hodgkin Lymphoma High Grade Module 29 (EORTC-QLQ-NHL-HG29) | Approximately 58 months | Patient-reported symptom burden, neuropathy, and physical condition/fatigue as measured by the EORTC-QLQ-NHL-HG29 questionnaire. The EORTC-QLQ-NHL-HG29 is the NHL-aggressive module of QLQ-C30; and it consists of 5 scales: Symptom burden due to disease and/or treatment (7 items), Neuropathy (2 items), Physical condition/Fatigue (5 items), Emotional impacts (4 items), and Worries/Fears health and functioning (11 items). Items are rated using a 4-point response scale ("not at all," "a little," "quite a bit," and "very much"). A higher score for all the multi-item scales and items represents a higher level of symptomatology or problems. |
| Health-Related Quality of Life (HRQoL) as Assessed by the European Organisation of Research and Treatment of Cancer-Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) | Approximately 58 months | Patient-reported global health status (GHS), role, and physical function as measured by the EORTC-QLQ-C30 questionnaire. The EORTC QLQ-30 contains 30 questions that incorporate 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The participant answers questions about their health during the past week. There are 28 questions answered on a 4-point scale where 1 =Not at all (best) to 4 =Very Much (worst) and 2 questions answered on a 7-point scale where 1 =Very poor (worst) to 7 =Excellent (best). |
| Number of participants with treatment-emergent adverse events (TEAEs) | From the first dose of study drug(s) to 30 days after the last dose; up to approximately 58 months | Number of participants with TEAEs, including laboratory values, vital signs, electrocardiogram results, and physical examination findings, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0. |
Countries
Argentina, Australia, Austria, Brazil, China, France, Germany, Italy, Japan, New Zealand, Poland, Puerto Rico, South Korea, Spain, Turkey (Türkiye), United Kingdom, United States
Contacts
CONTACTStudy Director
STUDY_DIRECTORStudy Director
BeOne Medicines
Outcome results
None listed