Mantle Cell Lymphoma; Non-Hodgkin Lymphoma
Conditions
Keywords
MCL, NHL, BTKi
Brief summary
This is a randomized study to compare the efficacy and safety of zanubrutinib plus rituximab versus bendamustine plus rituximab in previously untreated participants with mantle cell lymphoma (MCL) who are not eligible for stem cell transplantation.
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
DRUGzanubrutinib
Administered as two 80 mg capsules by mouth twice a day
DRUGbendamustine
Administered intravenously at a dose of 90 mg/m2/day on Days 1 and 2 of Cycles 1 to 6
DRUGrituximab
Administered intravenously at a dose of 375 mg/m2 on Day 1 of Cycles 1 to 6
Sponsors
BeOne Medicines
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. ≥70 years of age at the time of informed consent, OR ≥60 and \<70 years of age with comorbidities precluding autologous stem cell transplantation 2. Histologically confirmed diagnosis of MCL 3. No prior systemic treatments for MCL 4. Measurable disease by CT/MRI 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 6. Adequate marrow and organ function Key
Exclusion criteria
1. Known central nervous system involvement by lymphoma 2. Participants for whom the goal of therapy is tumor debulking prior to stem cell transplant 3. Clinically significant cardiovascular disease 4. History of severe bleeding disorder 5. Unable to swallow capsules or disease significantly affecting gastrointestinal function 6. Active fungal, bacterial and/or viral infection requiring systemic therapy 7. Requires ongoing treatment with a strong CYP3A inhibitor or inducer NOTE: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) determined by independent central review | Up to approximately 7 years | PFS is defined as the time from randomization to the date of first documentation of disease progression or death, whichever occurs first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS by investigator assessment | Up to approximately 7 years | PFS is defined as the time from randomization to the date of first documentation of disease progression or death, whichever occurs first. |
| Overall response rate (ORR) | Up to approximately 7 years | ORR is defined as the percentage of participants who achieve a complete response (CR) or partial response (PR), determined by independent central review and by investigator assessment. |
| Duration of response (DOR) | Up to approximately 7 years | DOR, as determined by independent central review and by investigator assessment, and defined as the time from the date that response criteria are first met to the date that disease progression is objectively documented or death, whichever occurs first. |
| Overall survival (OS) | Up to approximately 7 years | OS is defined as the time from randomization to the date of death due to any reason. |
| Time to Response (TTR) | Up to approximately 7 years | TTR, as determined by independent central review and by investigator assessment, and defined as the time from randomization to the first documentation of response. |
| Rate of complete response (CR) or complete metabolic response | Up to approximately 7 years | Rate of CR or complete metabolic response is defined as the percentage of participants who achieve a CR or complete metabolic response, determined by independent central review and by investigator assessment. |
| Participant-reported outcomes (PROs) as assessed by the European Quality of Life 5-Dimension 5 Level Questionnaire (EQ-5D-5L) | Up to approximately 7 years | EuroQoL-Five Dimensions, Five Levels (EQ-5D-5L) is a generic, self-reported measure of utility that consists of a five-item descriptive system and a visual analogue scale (EQ VAS). The descriptive system involves five health dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Participants may choose from the following response levels: no problems=1; slight problems=2; moderate problems=3; severe problems=4; and unable to/extreme problems=5. Higher values indicate worst health. |
| PROs as assessed by the European Organization for Research on Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) | Up to approximately 7 years | 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 adverse events and serious adverse events | Up to approximately 7 years | Number of participants with adverse events and serious adverse events, including laboratory values, vital signs, and physical examination findings. |
Countries
Australia, Austria, Belgium, Canada, China, France, Germany, Ireland, Italy, Japan, Netherlands, New Zealand, Poland, Portugal, Romania, Russia, Spain, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom, United States
Contacts
STUDY_DIRECTORStudy Director
BeOne Medicines
Outcome results
None listed