A Phase 2, Open-label Study of Zanubrutinib (BGB-3111) in Patients with Relapsed or Refractory Marginal Zone Lymphoma - NA

BEIGENE USA, INC.0 sites65 target enrollmentNovember 4, 2020

ConditionsRelapsed or Refractory Marginal Zone Lymphoma MedDRA version: 20.0Level: PTClassification code 10076596Term: Marginal zone lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Relapsed or Refractory Marginal Zone Lymphoma
Sponsor: BEIGENE USA, INC.
Enrollment: 65
Status: Active, not recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

November 4, 2020

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

BEIGENE USA, INC.

Eligibility Criteria

Inclusion Criteria

•Each patient eligible to participate in this study must meet all the following criteria:
•1\. Age 18 years or older
•2\. Histologically confirmed diagnosis of MZL including splenic, nodal, and extranodal subtypes (nodal MZL enrollment is capped at 30 patients). Gastric MZL must be H. pylori\-negative disease or H. pylori\-positive disease that has remained stable, progressed, or relapsed following antibiotic therapy. Patients with a screening serum immunoelectrophoresis result indicating a monoclonal spike must have a possible diagnosis of Waldenström's macroglobulinemia ruled out.
•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 PD after, the most recent systemic treatment
•4\. Current need for systemic therapy for MZL in the opinion of the investigator
•5\. Availability of archival tissue or consent to obtain fresh tumor tissue sample from an evaluable core or excisional biopsy (approximately 10 to 15 unstained formalin fixed paraffin embedded slides or tissue box).
•6\. Measurable disease by CT or MRI. Measurable disease is defined as \= 1 nodal lesion \> 1\.5 cm in longest diameter and/or \= 1 extranodal lesion \> 1\.0 cm in longest diameter, and lesion(s) measurable in 2 perpendicular diameters. Patients with spleen\-only disease are not considered to have measurable disease
•7\. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

Exclusion Criteria

•Each patient eligible to participate in this study must not meet any of the following exclusion criteria:
•1\. Known transformation to aggressive lymphoma, eg, large cell lymphoma. Clinically suspected transformation will require a biopsy of the suspected area prior to enrollment to confirm absence of transformation
•2\. Clinically significant cardiovascular disease (as defined in Section 4\.2\)
•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 within 180 days before first dose of study drug
•6\. Severe or debilitating pulmonary disease
•7\. Unable to swallow capsules or disease significantly affecting gastrointestinal function such as malabsorption syndrome, resection of the stomach or small bowel, bariatric surgery procedures, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction
•8\. Active fungal, bacterial and/or viral infection requiring systemic therapy
•9\. Known central nervous system involvement by lymphoma