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

2017-03-28 23:38:22 | BioPortfolio

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.

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

Study Design

Conditions

Lymphoma, B-Cell, Marginal Zone

Intervention

Ibrutinib

Location

Samsung Medical Center
Seoul
Korea, Republic of
169608

Status

Recruiting

Source

National Cancer Centre, Singapore

Results (where available)

View Results

Links

Published on BioPortfolio: 2017-03-28T23:38:22-0400

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