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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

Study acronym: MANGROVE
StatusActive, Not Recruiting
PhasePhase 3
Started2019-08-20
View on ClinicalTrials.gov ↗

Amendment history

2026-10-01
Primary completion confirmed: April 2026 (last estimated March 2027)
2026-05-15
Study Identification, Study Status, Sponsor/Collaborators, Study Description, Contacts/Locations, IPDSharing v32
Completion date2027-12→2031-09-30
Lead sponsorBeiGene→BeOne Medicines
Study description+209 characters
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.
Study sitesdetails revised at 4 of 176 sites
2025-09-25
Study Status v31
Re-verified, no change to tracked fields
2025-02-20
Study Identification, Study Status, Conditions, Arms and Interventions, Outcome Measures, Contacts/Locations, IPDSharing v30
Start date2019-08-21→2019-08-20
Secondary endpoints7 to 9 entries
PFS by investigator assessment Time to Response (TTR) Rate of complete response (CR) or complete metabolic response Participant-reported outcomes (PROs) as assessed by the European Quality of Life 5-Dimension 5 Level Questionnaire (EQ-5D-5L questionnaire) PROs as assessed by the European Organization for Research on Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30 questionnaire) Occurrence and severityNumber of treatment-emergentparticipants with adverse events (safety and tolerability)serious adverse events
Study title+90 characters
A Study Comparingto Investigate the Efficacy of Zanubrutinib +Plus Rituximab VersusCompared With Bendamustine +Plus Rituximab in ParticipantsAdults With Previously Untreated Mantle Cell Lymphoma Who Are Ineligible for Stem Cell Transplantation
2024-12-04
Study Status, Contacts/Locations v29
Study sites157→176
Show 28 earlier versions
2024-10-25
Study Status, Contacts/Locations v28
Study sites16→157
2024-01-09
Recruiting→Active, Not Recruiting Study Identification, Study Status, Study Design, Contacts/Locations v27
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 500→confirmed 510
Study sitesdetails revised at 16 of 16 sites
2023-08-23
Study Status, Contacts/Locations v26
Study sites39→16
2023-08-10
Study Status, Contacts/Locations v25
Study sites77→39
2023-07-26
Study Status, Contacts/Locations v24
Study sites83→77
2023-07-21
Study Status, Contacts/Locations v23
Study sites208→83
2023-07-10
Study Status, Contacts/Locations v22
Study sites127→208
2022-09-06
Study Status, Contacts/Locations v21
Study sites124→127
2022-04-25
Study Status, Contacts/Locations v20
Study sites122→124
2022-03-14
Study Status, Eligibility v19
Eligibility criteria+5 characters
Key Inclusion Criteria: ≥70 years of age at the time of informed consent, OR 65-69≥60 and <70 years of age with comorbidities precluding autologous stem [...]
2021-11-29
2 amendments v17-v18
2 re-verifications since 2021-11-17, no change to tracked fields
2021-10-05
Study Status v16
Primary completion date2021-09→2027-03
Completion date2026-08→2027-12
2021-08-31
Study Status v15
Primary completion date2021-07→2021-09
2021-06-20
Study Status, Contacts/Locations v14
Study sites120→122
2021-05-06
Study Status, Contacts/Locations v13
Study sites107→120
2021-04-21
Study Status, Contacts/Locations v12
Study sites82→107
2020-10-08
Study Status, Contacts/Locations v11
Study sites67→82
2020-09-01
Study Status, Arms and Interventions, Contacts/Locations v10
Study sites58→67
2020-07-27
Study Status, Contacts/Locations v9
Study sites42→58
2020-06-08
Study Status, Contacts/Locations v8
Study sitesdetails revised at 4 of 42 sites
2020-05-26
Study Status, Arms and Interventions, Eligibility, Contacts/Locations v7
Study sites27→42
Eligibility criteria+77 characters
Key Inclusion Criteria: ≥ 70 years of age at the time of informe [...] erformance status of 0-2 Adequate marrow and organ function Key Exclusion Criteria: Known central nervous system involvement [...] s ongoing treatment with a strong CYP3A inhibitor or inducer NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
2020-04-20
Study Identification, Study Status, Study Description, Outcome Measures, Eligibility, Contacts/Locations v6
Study sites1→27
Eligibility criteria+4 characters
[...] teria: Known central nervous system involvement by lymphoma PatientsParticipants for whom the goal of therapy is tumor debulking prior to st [...]
Secondary endpoints7 entries, revised
PatientParticipant-reported outcomes (PROs) as assessed by the EQ-5D-5L questionnaire
Study title+4 characters
Study Comparing Zanubrutinib + Rituximab Versus Bendamustine + Rituximab in PatientsParticipants With Untreated Mantle Cell Lymphoma
2020-02-04
3 amendments v3-v5
3 re-verifications since 2019-10-02, no change to tracked fields
2019-09-17
Study Status v2
Start dateestimated 2019-06→confirmed 2019-08-21
2019-06-27
Study Status, Outcome Measures v1
Secondary endpoints7 entries, revised
Patient-reported outcomes (PROs) as measuredassessed by the EQ-5D-5L questionnaire PROs as measuredassessed by the EORTC QLQ-C30 questionnaire
2019-06-27
Original filing
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.
Trial Details
NCT Number NCT04002297
Lead Sponsor BeOne Medicines
Conditions Mantle Cell Lymphoma; Non-Hodgkin Lymphoma
Enrollment 510 participants
Start Date 2019-08-20
Primary Completion 2026-04-27 (estimated)
Study Completion 2031-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-09-30