A Study of Zanubrutinib Plus Anti-CD20 Versus Lenalidomide Plus Rituximab in Participants With Relapsed/Refractory Follicular or Marginal Zone Lymphoma (MAHOGANY)
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| ClinicalTrials.gov Identifier: NCT05100862 |
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Recruitment Status :
Recruiting
First Posted : October 29, 2021
Last Update Posted : April 24, 2024
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Sponsor:
BeiGene
Information provided by (Responsible Party):
BeiGene
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Brief Summary:
The purpose of the study is to compare the efficacy of zanubrutinib plus obinutuzumab versus lenalidomide plus rituximab (R^2) in participants with relapsed/refractory (R/R) follicular lymphoma (FL), as measured by progression-free survival as determined by an independent review committee in accordance with the 2014 modification of the International Working Group on non-Hodgkin lymphoma (NHL) Criteria based on n positron emission tomography and computed tomography (PET/CT), and to compare the efficacy of zanubrutinib plus rituximab versus R^2 in participants with R/R marginal zone lymphoma (MZL), as measured by progression free survival (PFS) assessed by IRC in accordance with CT-based Lugano 2014 Criteria.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Relapsed/Refractory Follicular Lymphoma Marginal Zone Lymphoma | Drug: Zanubrutinib Drug: Rituximab Drug: Lenalidomide Drug: Obinutuzumab | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 750 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 3 Randomized, Open-Label Multicenter Study of Zanubrutinib (BGB-3111) Plus Anti-CD20 Antibodies Versus Lenalidomide Plus Rituximab in Patients With Relapsed/Refractory Follicular or Marginal Zone Lymphoma |
| Actual Study Start Date : | March 10, 2022 |
| Estimated Primary Completion Date : | July 2028 |
| Estimated Study Completion Date : | June 2030 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Lymphoma
| Arm | Intervention/treatment |
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Experimental: Follicular Lymphoma Arm A: Zanubrutinib plus Obinutuzumab
Participants will receive zanubrutinib and Obinutuzumab. Following the completion of the combination treatment, participants will continue receiving zanubrutinib monotherapy until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination, whichever occurs first.
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Drug: Zanubrutinib
Zanubrutinib will be administered orally as two 80-milligram (mg) capsules twice a day (160 mg twice a day) or four 80-mg capsules once a day (320 mg once a day) continuously in repeated 28-day cycles.
Other Names:
Drug: Obinutuzumab Obinutuzumab will be administered at a dose of 1000 mg on Cycle 1 Days 1, 8, 15 and then on Cycles 2 to 6 Day 1. |
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Active Comparator: Follicular Lymphoma Arm B: Lenalidomide plus Rituximab
Participants will receive lenalidomide and rituximab.
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Drug: Rituximab
Rituximab will be administered intravenously at a dose of 375 mg/meter squared on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. Each cycle is 28 days in length.
Other Names:
Drug: Lenalidomide Lenalidomide will be administered orally as 20-mg capsules (10 mg if creatinine clearance ≥ 30 mL/min but < 60 mL/min) once a day on Days 1 to 21 of each 28-day cycle for a total of 12 cycles.
Other Name: Revlimid |
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Experimental: Marginal Zone Lymphoma Arm C: Zanubrutinib plus Rituximab
Participants will receive zanubrutinib and rituximab. Following the completion of the combination treatment, participants will continue receiving zanubrutinib monotherapy until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination, whichever occurs first.
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Drug: Zanubrutinib
Zanubrutinib will be administered orally as two 80-milligram (mg) capsules twice a day (160 mg twice a day) or four 80-mg capsules once a day (320 mg once a day) continuously in repeated 28-day cycles.
Other Names:
Drug: Rituximab Rituximab will be administered intravenously at a dose of 375 mg/meter squared on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. Each cycle is 28 days in length.
Other Names:
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Active Comparator: Marginal Zone Lymphoma Arm D: Lenalidomide plus Rituximab
Participants will receive lenalidomide and rituximab.
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Drug: Rituximab
Rituximab will be administered intravenously at a dose of 375 mg/meter squared on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. Each cycle is 28 days in length.
Other Names:
Drug: Lenalidomide Lenalidomide will be administered orally as 20-mg capsules (10 mg if creatinine clearance ≥ 30 mL/min but < 60 mL/min) once a day on Days 1 to 21 of each 28-day cycle for a total of 12 cycles.
Other Name: Revlimid |
Primary Outcome Measures :
- Progression-free Survival As Determined By A Blinded Independent Review Committee (BIRC) [ Time Frame: Approximately 78 months ]
Secondary Outcome Measures :
- Progression-free Survival As Determined By Investigator Assessment [ Time Frame: Approximately 87 months ]
- Duration Of Response As Determined By BIRC And By Investigator Assessment [ Time Frame: Approximately 87 months ]
- Overall Response Rate As Determined By BIRC And By Investigator Assessment [ Time Frame: Approximately 87 months ]
- Complete Response Rate As Determined By BIRC And By Investigator Assessment [ Time Frame: Approximately 87 months ]
- Time To Response As Determined By BIRC And By Investigator Assessment [ Time Frame: Approximately 87 months ]
- Time to Next Ant-Lymphoma Treatment [ Time Frame: Approximately 87 months ]
- Overall Survival [ Time Frame: Approximately 87 months ]
- Health-related Quality Of Life (HRQoL) Using EORTC QLQ-C30) [ Time Frame: Approximately 87 months ]HRQ0L assessed by The European Organization For Research On Treatment Of Cancer Quality Of Life Questionnaire-core 30 (EORTC QLQ-C30) consists of 30 questions that are associated with 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea and vomiting), and 6 single symptom items ( dyspnoea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The scores range from 0 to 100 and higher score indicates better quality of life.
- HRQoL Using European Quality of Life 5 Dimension 5 Level Questionnaire [EQ 5D 5L) [ Time Frame: Approximately 87 months ]The EQ-5D-5L is comprised of a descriptive module and a visual analogue scale. The EQ-5D-5L descriptive module comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The visual analogue scale records the respondent's self-rated health on a 0 to 100 scale, with 100 labeled "the best health you can imagine" and 0 labeled "the worst health you can imagine. Higher scores indicate better quality of life.
- HRQoL Using National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Lymphoma Symptom Index-18 [FLymSI 18) [ Time Frame: Approximately 87 months ]The FLymSI-18 is comprised of 18 questions which cover 4 sub-scales: physical symptoms, emotional symptoms, side effects, and functional well-being. Scores are based on the 5-level Likert scale with 5 possible responses ranging from 0 'Not at all' to 4 'Very much' and is divided into a total score. Higher score indicates better quality of life.
- Number of Participants Experiencing Adverse Events (AEs) [ Time Frame: From first dose to 28 days after the last dose of zanubrutinib or lenalidomide, 90 days after the last dose of obinutuzumab or rituximab, or until the date of confirmed disease progression, whichever comes later (Approximately 87 months) ]
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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:
- Histologically confirmed grade 1-3a FL or MZL
- Previously treated with ≥ 1 line of systemic therapy including anti-CD20 agent. Must have a documented failure to achieve at least partial response during the most recent systemic therapy or documented progressive disease after the most recent systemic therapy
- Need for systemic therapy for FL or MZL
- Measurable disease by computed tomography or magnetic resonance imaging
- Adequate bone marrow, liver and renal function
Key Exclusion Criteria:
- Transformation to aggressive lymphoma
- Requiring ongoing need for corticosteroid treatment
- Clinically significant cardiovascular disease
- Prior malignancy within the past 2 years
- Active fungal, bacterial, and/or viral infection that requires systemic therapy
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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): NCT05100862
Contacts
| Contact: Study Director BeiGene | 1-877-828-5568 | clinicaltrials@beigene.com |
Locations
Show 171 study locations
Sponsors and Collaborators
BeiGene
Investigators
| Study Director: | Study Director | BeiGene | |
| Principal Investigator: | Study Director | BeiGene |
| Responsible Party: | BeiGene |
| ClinicalTrials.gov Identifier: | NCT05100862 |
| Other Study ID Numbers: |
BGB-3111-308 CTR20232545 ( Registry Identifier: ChinaDrugTrials ) 2022-502548-12-00 ( Registry Identifier: EU CTIS ) |
| First Posted: | October 29, 2021 Key Record Dates |
| Last Update Posted: | April 24, 2024 |
| Last Verified: | April 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by BeiGene:
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Zanubrutinib BGB-3111 Rituximab Lenalidomide Obinutuzumab |
Additional relevant MeSH terms:
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Lymphoma Lymphoma, B-Cell, Marginal Zone Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin Lymphoma, B-Cell Rituximab Obinutuzumab Lenalidomide Zanubrutinib |
Antineoplastic Agents, Immunological Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Tyrosine Kinase Inhibitors Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |