The trial is taking place at:
C

Clinica Universidad de Navarra | Sede Madrid - Hematology Department

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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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BeiGene

Status and phase

Enrolling
Phase 3

Conditions

Relapsed/Refractory Follicular Lymphoma
Marginal Zone Lymphoma

Treatments

Drug: Rituximab
Drug: Zanubrutinib
Drug: Lenalidomide
Drug: Obinutuzumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT05100862
BGB-3111-308
CTR20232545 (Registry Identifier)
2022-502548-12-00 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment

750 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

750 participants in 4 patient groups

Follicular Lymphoma Arm A: Zanubrutinib plus Obinutuzumab
Experimental group
Description:
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.
Treatment:
Drug: Obinutuzumab
Drug: Zanubrutinib
Follicular Lymphoma Arm B: Lenalidomide plus Rituximab
Active Comparator group
Description:
Participants will receive lenalidomide and rituximab.
Treatment:
Drug: Lenalidomide
Drug: Rituximab
Marginal Zone Lymphoma Arm C: Zanubrutinib plus Rituximab
Experimental group
Description:
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.
Treatment:
Drug: Zanubrutinib
Drug: Rituximab
Marginal Zone Lymphoma Arm D: Lenalidomide plus Rituximab
Active Comparator group
Description:
Participants will receive lenalidomide and rituximab.
Treatment:
Drug: Lenalidomide
Drug: Rituximab

Trial contacts and locations

184

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Central trial contact

Study Director BeiGene

Data sourced from clinicaltrials.gov

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