NCT03093831

Phase II Study of Ibrutinib in Patients With Relapsed or Refractory Marginal Zone Lymphoma

A Phase II Investigator Sponsored Multi-Centre Trial of the Bruton's Tyrosine Kinase (BTK) Inhibitor Ibrutinib in Patients With Relapsed or Refractory Marginal Zone Lymphoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: National Cancer Centre, Singapore · Academic / Other
• Sex: All
• Age: 21 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the efficacy and safety of Ibrutinib in predominantly Asian patients with relapsed or refractory marginal zone lymphoma.

Detailed description

Patient sample: Patients with histologically proven marginal zone lymphoma (splenic, nodal and extra-nodal subtypes included). Other important requirements for recruitment into the study: * Prior treatment with one or more lines rituximab or rituximab-based chemoimmunotherapy with failure to achieve at least a partial response (PR) or documented disease progression * Age ≥ 21 years of age * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * At least 1 measurable disease site on computed tomography (CT) scan that is at least 1.5cm in the longest dimension. * Patient must have an indication for treatment e.g., symptoms from disease, bulky disease (\>5cm), threatened end-organ function, or cytopenias requiring transfusion or growth factor support Dosage and Dose Regimen: 560mg of Ibrutinib is administered orally once daily. Patients with mild liver impairment (Child's-Pugh A), ibrutinib 140mg (1 x 140mg capsule) will be administered instead. The patient will continue on treatment until one of the following occurs: * Patient has disease progression (as assessed by the investigator). * Patient has an intercurrent illness or adverse events that prevents further ibrutinib administration. * Patient decides to withdraw from the study. * Investigator considers withdrawal to be in the best interest of the patient. * Patient requires continuous therapy on a prohibited concomitant medication and no alternative medications or therapies are available as a replacement to the prohibited medication. * Patient is lost to follow-up. * Patient is non-compliant. * Patient becomes pregnant. * Study termination by the Sponsor or regulatory authority. * Death * Completed 3 years of ibrutinib treatment Assessment: CT Neck to pelvis or FDG-PET/CT skull base to mid-thigh to be performed repeated after every 12 weeks Statistical considerations: The primary objective of this study is to determine the efficacy of ibrutinib in Asian patients with relapsed or refractory MZL. We will consider an ORR of 50% to be desirable. Simon's 2-stage minimax design will be used to test the null hypothesis that the overall response rate will be less than or equal to 20% (response rate that is considered not clinically compelling). Twelve subjects will be included in the first stage, and if there are at least 3 responders, a total of 21 subjects will be enrolled. The treatment will be declared ineffective if there are less than 8 responders in total. This design has 90% power to detect an overall response rate of 50% at a 5% significance level. Study Endpoints: Primary: 1\. Overall response rates (complete remission \[CR\] + partial remission \[PR\]) Secondary: 1. Survival parameters * Progression-free survival * Overall survival 2. Safety * Frequency and severity of adverse events * Frequency of AE requiring discontinuation of study drug or dose reductions Total sample size: The planned sample size is 21 patients enrolled at multiple centres in Singapore and South Korea

Conditions

• Lymphoma, B-Cell, Marginal Zone

Interventions

Type	Name	Description
DRUG	Ibrutinib	560mg administered orally once daily.

Timeline

• Start date: 2016-07-08
• Primary completion: 2020-07-17
• Completion: 2020-07-17
• First posted: 2017-03-28
• Last updated: 2023-10-11

Locations

2 sites across 1 country: Singapore