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Report for Clinical Trial NCT03846427

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

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).

NCT03846427 Marginal Zone Lymphoma
MeSH:Lymphoma Lymphoma, B-Cell, Marginal Zone
HPO:Lymphoma

1 Interventions

Name: Zanubrutinib

Description: Zanubrutinib at a dose of 160 mg PO Twice a Day (BID)
Type: Drug
Group Labels: 1

Zanubrutinib


Primary Outcomes

Measure: Overall response rate (ORR) determined by independent central review

Time: Up to 3 years

Secondary Outcomes

Measure: ORR by investigator assessment

Time: Up to 3 years

Measure: Progression-free survival (PFS)

Time: Up to 3 years

Measure: Overall survival (OS)

Time: Up to 3 years

Measure: Duration of response (DOR)

Time: Up to 3 years

Measure: Time to response (TTR)

Time: Up to 3 years

Measure: Participant-reported outcomes (PROs) as measured by the EuroQo EQ-5D-5L questionnaire

Time: Up to 3 years

Measure: PROs as measured by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)

Time: Up to 3 years

Measure: Occurrence and severity of treatment-emergent adverse events (safety and tolerability)

Time: Up to 3 years

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 P4503A

Requires ongoing treatment with a strong Cytochrome P4503A (CYP3A) inhibitor or inducer 14. --- P4503A ---



HPO Nodes


HPO: