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Study of Zanubrutinib (BGB-3111) in Participants With Marginal Zone Lymphoma (MAGNOLIA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03846427
Recruitment Status : Active, not recruiting
First Posted : February 19, 2019
Last Update Posted : November 30, 2020
Sponsor:
Information provided by (Responsible Party):
BeiGene

Study Description
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Brief Summary:
This is a single arm study to evaluate the efficacy, safety and tolerability of zanubrutinib (BGB-3111) in participants with relapsed/refractory marginal zone lymphoma (R/R MZL).

Condition or disease Intervention/treatment Phase
Marginal Zone Lymphoma Drug: Zanubrutinib Phase 2

Detailed Description:
This is a Phase 2, open-label study of zanubrutinib in approximately 65 participants with R/R MZL. The study will evaluate efficacy, as measured by overall response rate, safety and tolerability.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Open-label Study of Zanubrutinib (BGB-3111) in Patients With Relapsed or Refractory Marginal Zone Lymphoma
Actual Study Start Date : February 19, 2019
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : August 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Zanubrutinib Drug: Zanubrutinib
Zanubrutinib at a dose of 160 mg PO Twice a Day (BID)
Other Name: BGB-3111


Outcome Measures
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Primary Outcome Measures :
  1. Overall response rate (ORR) determined by independent central review [ Time Frame: Up to 3 years ]

Secondary Outcome Measures :
  1. ORR by investigator assessment [ Time Frame: Up to 3 years ]
  2. Progression-free survival (PFS) [ Time Frame: Up to 3 years ]
  3. Overall survival (OS) [ Time Frame: Up to 3 years ]
  4. Duration of response (DOR) [ Time Frame: Up to 3 years ]
  5. Time to response (TTR) [ Time Frame: Up to 3 years ]
  6. Participant-reported outcomes (PROs) as measured by the EuroQo EQ-5D-5L questionnaire [ Time Frame: Up to 3 years ]
  7. PROs as measured by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) [ Time Frame: Up to 3 years ]
  8. Occurrence and severity of treatment-emergent adverse events (safety and tolerability) [ Time Frame: Up to 3 years ]

Eligibility Criteria
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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:

  1. Age 18 years or older
  2. Histologically confirmed diagnosis of MZL including splenic, nodal, and extranodal subtypes
  3. Previously received one or more lines of therapy including at least one CD20-directed regimen (either as monotherapy or as chemoimmunotherapy) with documented failure to achieve at least PR or documented progressive disease (PD) after, the most recent systemic treatment
  4. Current need for systemic therapy for MZL
  5. Measurable disease by CT or MRI
  6. Eastern Cooperative Oncology Group (ECOG) of 0-2
  7. Life expectancy ≥ 6 months
  8. Adequate bone marrow function
  9. Adequate organ function
  10. Male and female participants must use highly effective methods of contraception

Key Exclusion Criteria:

  1. Known transformation to aggressive lymphoma, eg, large cell lymphoma.
  2. Clinically significant cardiovascular disease
  3. Prior malignancy within the past 2 years, except for curatively treated basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score 6 prostate cancer
  4. History of severe bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention
  5. History of stroke or intracranial hemorrhage
  6. Severe or debilitating pulmonary disease
  7. Active fungal, bacterial and/or viral infection requiring systemic therapy
  8. Known central nervous system involvement by lymphoma
  9. Known infection with HIV, or serologic status reflecting active viral hepatitis B (HBV) or viral hepatitis C (HCV) infection
  10. Major surgery within 4 weeks of the first dose of study drug
  11. Prior treatment with a Bruton tyrosine kinase (BTK) inhibitor
  12. Pregnant or lactating women
  13. Requires ongoing treatment with a strong Cytochrome P4503A (CYP3A) inhibitor or inducer
  14. Concurrent participation in another therapeutic clinical trial

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): NCT03846427


Locations
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Sponsors and Collaborators
BeiGene
Investigators
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Study Director: Melannie Co, MD BeiGene
More Information
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Publications:
Stephen Opat, Robert Marcus, MA, FRCP, FRCPath, Craig A. Portell, MD, William Reed, MD, Chris Tankersley, Jane Huang, MD, Judith Trotman, MBChB, FRACP, FRCPA. Phase 2 Study of Zanubrutinib (BGB-3111) in Patients with Relapsed/Refractory Marginal Zone Lymphoma. Blood. 2019; 134(1):5256. https://doi.org/10.1182/blood-2019-122629

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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT03846427    
Other Study ID Numbers: BGB-3111-214
2018-001284-24 ( EudraCT Number )
CTR20180823 ( Registry Identifier: Center for drug evaluation, CFDA )
First Posted: February 19, 2019    Key Record Dates
Last Update Posted: November 30, 2020
Last Verified: November 2020
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:
BGB-3111
Zanubrutinib
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, B-Cell
Lymphoma, Non-Hodgkin
Zanubrutinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action