Description:
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.
Title
- Brief Title: Study of ME-401 in Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma (NHL)
- Official Title: A Japanese Phase 2 Study of ME-401 in Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma (NHL)
Clinical Trial IDs
- ORG STUDY ID:
ME-401-K02
- NCT ID:
NCT04533581
Conditions
- Indolent B-cell Non-Hodgkin's Lymphoma
Interventions
Drug | Synonyms | Arms |
---|
ME-401 | | ME-401 |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
ME-401 | Experimental | | |
Eligibility Criteria
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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 20 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Objective response rate (ORR) |
Time Frame: | Up to approximately 2 years |
Safety Issue: | |
Description: | 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). |
Secondary Outcome Measures
Measure: | Efficacy of ME-401 as assessed by the duration of response (DOR) |
Time Frame: | Up to approximately 4 years |
Safety Issue: | |
Description: | |
Measure: | Efficacy of ME-401 as assessed by the progression-free survival (PFS) |
Time Frame: | Up to approximately 4 years |
Safety Issue: | |
Description: | |
Measure: | Efficacy of ME-401 as assessed by CR |
Time Frame: | Up to approximately 4 years |
Safety Issue: | |
Description: | |
Measure: | Efficacy of ME-401 as assessed by the Time to treatment failure (TTF) |
Time Frame: | Up to approximately 4 years |
Safety Issue: | |
Description: | |
Measure: | Efficacy of ME-401 as assessed by the objective response rate (ORR) |
Time Frame: | Up to approximately 4 years |
Safety Issue: | |
Description: | |
Measure: | Safety of ME-401 as assessed by the number of participants with treatment-emergent adverse events (TEAEs) |
Time Frame: | Up to approximately 4 years |
Safety Issue: | |
Description: | |
Measure: | Safety of ME-401 as assessed by the time to occurrence of adverse event of special interest (AESI) |
Time Frame: | Up to approximately 4 years |
Safety Issue: | |
Description: | |
Measure: | Plasma concentration level of ME-401 |
Time Frame: | Up to approximately 4 years |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Kyowa Kirin Co., Ltd. |
Last Updated
October 5, 2020