Trial purpose
Cancer treatment
Tumor type
Haematological
Age
18+
Clinical summary
Summary
This study is recruiting people with relapsed or refractory Follicular Lymphoma (FL) and Marginal Zone Lymphoma (MZL), and is testing different treatments depending on which disease you have.
People with Follicular Lymphoma will be randomly allocated to either the Experimental or Active Comparator Arms.
- In the Experimental Arm, people with FL will receive a combination of targeted therapies: zanubrutinib and obinutuzumab. Once they have finished receiving the combination treatment, participants will continue receiving zanubrutinib alone.
- In the Active Comparator Arm, people with FL will receive targeted therapy (rituximab) plus lenalidomide, which is a drug that modifies the response of the immune system.
People with Marginal Zone Lymphoma will be randomly allocated to either an Experimental or Active Comparator Arm.
- In the Experimental Arm, people with MZL will receive combination targeted therapy (zanubrutinib + rituximab). Once they have finished receiving the combination treatment, participants will continue receiving zanubrutinib alone.
- In the Active Comparator Arm, people with MZL will receive targeted therapy (rituximab) plus lenalidomide, which is a drug that modifies the response of the immune system.
Conditions
This trial is treating people with relapsed or refractory follicular lymphoma and marginal zone lymphoma
Eligibility
Inclusion
- 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
Exclusion
- 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
Inclusion
- You have had treatment, but your cancer has come back (relapsed or recurrent).
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
- You are able to swallow medication by mouth.
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
BeiGene Australia Pty Ltd
Scientific 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
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