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NCT Number: NCT04002297

A Study to Investigate the Efficacy of Zanubrutinib Plus Rituximab Compared With Bendamustine Plus Rituximab in Adults With Previously Untreated Mantle Cell Lymphoma Who Are Ineligible for Stem Cell Transplantation

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Mantle Cell Lymphoma; Non-Hodgkin Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Canberra Hospital, Garran, Australian Capital Territory, Australia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • ≥70 years of age at the time of informed consent, OR ≥60 and <70 years of age with comorbidities precluding autologous stem cell transplantation
  • Histologically confirmed diagnosis of MCL
  • No prior systemic treatments for MCL
  • Measurable disease by CT/MRI
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Adequate marrow and organ function

Key Exclusion Criteria:

  • Known central nervous system involvement by lymphoma
  • Participants for whom the goal of therapy is tumor debulking prior to stem cell transplant
  • Clinically significant cardiovascular disease
  • History of severe bleeding disorder
  • Unable to swallow capsules or disease significantly affecting gastrointestinal function
  • Active fungal, bacterial and/or viral infection requiring systemic therapy
  • Requires ongoing treatment with a strong CYP3A inhibitor or inducer

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Treatment and study plan

Zanubrutinib

Drug

Administered as two 80 mg capsules by mouth twice a day

Other names: BGB-3111, Brukinsa

Bendamustine

Drug

Administered intravenously at a dose of 90 mg/m2/day on Days 1 and 2 of Cycles 1 to 6

Rituximab

Drug

Administered intravenously at a dose of 375 mg/m2 on Day 1 of Cycles 1 to 6

Primary outcomes

  1. Progression-free survival (PFS) determined by independent central review

    Time frame: 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 outcomes

  1. PFS by investigator assessment

    Time frame: 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.

  2. Overall response rate (ORR)

    Time frame: 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.

  3. Duration of response (DOR)

    Time frame: 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.

  4. Overall survival (OS)

    Time frame: Up to approximately 7 years

    OS is defined as the time from randomization to the date of death due to any reason.

  5. Time to Response (TTR)

    Time frame: 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.

  6. Rate of complete response (CR) or complete metabolic response

    Time frame: 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.

  7. Participant-reported outcomes (PROs) as assessed by the European Quality of Life 5-Dimension 5 Level Questionnaire (EQ-5D-5L)

    Time frame: 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.

  8. PROs as assessed by the European Organization for Research on Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)

    Time frame: 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).

  9. Number of participants with adverse events and serious adverse events

    Time frame: Up to approximately 7 years

    Number of participants with adverse events and serious adverse events, including laboratory values, vital signs, and physical examination findings.

Sponsors and collaborators

Lead sponsor

BeOne Medicines

Industry

Registry information

Official study title

A Phase 3 Randomized, Open-Label, Multicenter Study Comparing Zanubrutinib (BGB-3111) Plus Rituximab Versus Bendamustine Plus Rituximab in Patients With Previously Untreated Mantle Cell Lymphoma Who Are Ineligible for Stem Cell Transplantation

Acronym: MANGROVE

Important dates

Study start
2019
Primary completion
2027
Study completion
2031
First posted
Jun 28, 2019
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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