Study of ME-401 in Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma (NHL)

Phase 2Active Not RecruitingNCT04533581

Kyowa Kirin Co., Ltd.61 enrolled

Overview

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of ME-401 in the treatment of Japanese participants with Relapsed or Refractory indolent B-Cell Non-Hodgkin's Lymphoma.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Indolent B-cell Non-Hodgkin's Lymphoma

Interventions

ME-401DRUG

In the first 2 cycles (1 cycle is 28 days), subjects will be administered 60 mg of ME-401 orally once a day on a continuous schedule (CS). After that, subjects will be administered 60 mg of ME-401 orally once a day for the first 7 days, followed by rest for 21 days on an intermittent schedule (IS).

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients aged 20 years or older at the submission of the written informed consent form * Patients that have undergone therapy after at least 2 prior systemic therapies (anti-CD20 Ab, chemo, and so on) for relapsed or refractory B-cell NHL * Patients who have not undergone phosphatidylinositol 3-kinase (PI3K) inhibitors to date * Patients who have not undergone Bruton's tyrosine kinase (BTK) inhibitors to date * Patients with Eastern Cooperative Oncology Group Performance status (ECOG PS) "0 or 1" Exclusion Criteria: * Patients with relapsed or refractory B-cell NHL who is categorized into Small lymphocytic lymphoma (SLL), Waldenström's macroglobulinemia (WM), Lymphoplasmacytic lymphoma (LPL) by WHO classification * Patients who have been histologically confirmed FL Grade 3b transformation from Follicular lymphoma (FL) to an aggressive lymphoma at least once * Patients with lymphomatous involvement of the central nervous system * Patients with uncontrolled clinically significant illness * Patients with active interstitial lung disease or a history thereof

Locations (30)

Outcomes

Primary Outcomes

Objective response rate (ORR)

ORR is measured as the proportion of subjects achieving the best response rating of complete response (CR) or partial response (PR) prior to first progressive disease (PD).

Time frame: Up to approximately 2 years