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A Study of Zanubrutinib Versus Lenalidomide in Participants With Relapsed/Refractory Follicular or Marginal Zone Lymphoma (MAHOGANY)

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ClinicalTrials.gov Identifier: NCT05100862
Recruitment Status : Recruiting
First Posted : October 29, 2021
Last Update Posted : November 17, 2022
Sponsor:
Information provided by (Responsible Party):
BeiGene

Study Description
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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 Design
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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 : August 2028
Estimated Study Completion Date : June 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: Zanubrutinib
Zanubrutinib will be administered orally as two 80-milligram (mg) capsules twice a day (160 mg twice a day or 320 mg once a day) continuously in repeated 28-day cycles.
Other Names:
  • BGB-3111
  • Brukinsa

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.
Active Comparator: Follicular Lymphoma Arm B: Lenalidomide plus Rituximab
Participants will receive lenalidomide and rituximab.
 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:
  • Rituxan
  • MabThera
  • Ruxience
  • Truxima

Drug: Lenalidomide
Lenalidomide will be administered orally as 20-mg capsules once a day on Days 1 to 21 of each 28-day cycle for a total of 12 cycles.
Other Name: Revlimid
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.
 Drug: Zanubrutinib
Zanubrutinib will be administered orally as two 80-milligram (mg) capsules twice a day (160 mg twice a day or 320 mg once a day) continuously in repeated 28-day cycles.
Other Names:
  • BGB-3111
  • Brukinsa

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:
  • Rituxan
  • MabThera
  • Ruxience
  • Truxima
Active Comparator: Marginal Zone Lymphoma Arm D: Lenalidomide plus Rituximab
Participants will receive lenalidomide and rituximab.
 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:
  • Rituxan
  • MabThera
  • Ruxience
  • Truxima

Drug: Lenalidomide
Lenalidomide will be administered orally as 20-mg capsules once a day on Days 1 to 21 of each 28-day cycle for a total of 12 cycles.
Other Name: Revlimid


Outcome Measures
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Primary Outcome Measures :
  1. Progression-free Survival As Determined By An Independent Review Committee [ Time Frame: Approximately 78 months ]

Secondary Outcome Measures :
  1. Progression-free Survival As Determined By Investigator Assessment [ Time Frame: Approximately 87 months ]
  2. Duration Of Response As Determined By An Independent Review Committee And By Investigator Assessment . [ Time Frame: Approximately 87 months ]
  3. Overall Response Rate As Determined By An Independent Review Committee And By Investigator Assessment [ Time Frame: Approximately 87 months ]
  4. Complete Response Rate As Determined By An Independent Review Committee And By Investigator Assessment [ Time Frame: Approximately 87 months ]
  5. Time To Response As Determined By An Independent Review Committee And By Investigator Assessment [ Time Frame: Approximately 87 months ]
  6. Time to Next Ant-Lymphoma Treatment [ Time Frame: Approximately 87 months ]
  7. Overall Survival [ Time Frame: Approximately 87 months ]
  8. 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.

  9. 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.

  10. 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.

  11. 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) ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 received ≥ 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.

Contacts and Locations
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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
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Contact: Study Director BeiGene 1-877-828-5568 clinicaltrials@beigene.com

Locations
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United States, New York
Clinical Research Alliance, Inc. Recruiting
Westbury, New York, United States, 11590
Sponsors and Collaborators
BeiGene
Investigators
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Study Director: Study Director BeiGene
Principal Investigator: Study Director BeiGene
More Information
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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT05100862    
Other Study ID Numbers: BGB-3111-308
First Posted: October 29, 2021    Key Record Dates
Last Update Posted: November 17, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by BeiGene:
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
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action