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

Primary Purpose

Indolent B-cell Non-Hodgkin's Lymphoma

Status
Active
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
ME-401
Sponsored by
Kyowa Kirin Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Indolent B-cell Non-Hodgkin's Lymphoma

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Anjo Kosei Hospital
  • Aichi Cancer Center Hospital
  • Japanese Red Cross Nagoya Daini Hospital
  • National Hospital Organization Nagoya Medical Center
  • Kameda Medical Center
  • National Hospital Organization Shikoku Cancer Center
  • Gunma University Hospital
  • Chugoku Central Hospital
  • Hokkaido University Hospital
  • Ishikawa Prefectural Central Hospital
  • Mie University Hospital
  • Tohoku University Hospital
  • Kurashiki Central Hospital
  • Kindai University Hospital
  • Osaka University Hospital
  • Saitama Medical University International Medical Center
  • Jichi Medical University Hospital
  • Tokyo Metropolitan Komagome Hospital
  • National Cancer Center Hospital
  • The Cancer Institute Hospital Of JFCR
  • Tottori University Hospital
  • Akita University Hospital
  • Aomori Prefectural Central Hospital
  • Chiba Cancer Center
  • Kyushu University Hospital
  • National Hospital Organization Kyushu Medical Center
  • Kagoshima University Hospital
  • National Hospital Organization Kumamoto Medical Center
  • Japanese Red Cross Kyoto Daini Hospital
  • Okayama University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ME-401

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Efficacy of ME-401 as assessed by the duration of response (DOR)
Efficacy of ME-401 as assessed by the progression-free survival (PFS)
Efficacy of ME-401 as assessed by CR
Efficacy of ME-401 as assessed by the Time to treatment failure (TTF)
Efficacy of ME-401 as assessed by the objective response rate (ORR)
Safety of ME-401 as assessed by the number of participants with treatment-emergent adverse events (TEAEs)
Safety of ME-401 as assessed by the time to occurrence of adverse event of special interest (AESI)
Plasma concentration level of ME-401

Full Information

First Posted
August 26, 2020
Last Updated
August 6, 2023
Sponsor
Kyowa Kirin Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04533581
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 17, 2020 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kyowa Kirin Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Indolent B-cell Non-Hodgkin's Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ME-401
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ME-401
Intervention Description
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).
Primary Outcome Measure Information:
Title
Objective response rate (ORR)
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).
Time Frame
Up to approximately 2 years
Secondary Outcome Measure Information:
Title
Efficacy of ME-401 as assessed by the duration of response (DOR)
Time Frame
Up to approximately 4 years
Title
Efficacy of ME-401 as assessed by the progression-free survival (PFS)
Time Frame
Up to approximately 4 years
Title
Efficacy of ME-401 as assessed by CR
Time Frame
Up to approximately 4 years
Title
Efficacy of ME-401 as assessed by the Time to treatment failure (TTF)
Time Frame
Up to approximately 4 years
Title
Efficacy of ME-401 as assessed by the objective response rate (ORR)
Time Frame
Up to approximately 4 years
Title
Safety of ME-401 as assessed by the number of participants with treatment-emergent adverse events (TEAEs)
Time Frame
Up to approximately 4 years
Title
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
Title
Plasma concentration level of ME-401
Time Frame
Up to approximately 4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Anjo Kosei Hospital
City
Anjo
State/Province
Aichi
Country
Japan
Facility Name
Aichi Cancer Center Hospital
City
Nagoya
State/Province
Aichi
Country
Japan
Facility Name
Japanese Red Cross Nagoya Daini Hospital
City
Nagoya
State/Province
Aichi
Country
Japan
Facility Name
National Hospital Organization Nagoya Medical Center
City
Nagoya
State/Province
Aichi
Country
Japan
Facility Name
Kameda Medical Center
City
Kamogawa
State/Province
Chiba
Country
Japan
Facility Name
National Hospital Organization Shikoku Cancer Center
City
Matsuyama
State/Province
Ehime
Country
Japan
Facility Name
Gunma University Hospital
City
Maebashi
State/Province
Gunma
Country
Japan
Facility Name
Chugoku Central Hospital
City
Fukuyama
State/Province
Hiroshima
Country
Japan
Facility Name
Hokkaido University Hospital
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
Ishikawa Prefectural Central Hospital
City
Kanazawa
State/Province
Ishikawa
Country
Japan
Facility Name
Mie University Hospital
City
Tsu
State/Province
Mie
Country
Japan
Facility Name
Tohoku University Hospital
City
Sendai
State/Province
Miyagi
Country
Japan
Facility Name
Kurashiki Central Hospital
City
Kurashiki
State/Province
Okayama
Country
Japan
Facility Name
Kindai University Hospital
City
Osakasayama
State/Province
Osaka
Country
Japan
Facility Name
Osaka University Hospital
City
Suita
State/Province
Osaka
Country
Japan
Facility Name
Saitama Medical University International Medical Center
City
Hidaka
State/Province
Saitama
Country
Japan
Facility Name
Jichi Medical University Hospital
City
Shimotsuke
State/Province
Tochigi
Country
Japan
Facility Name
Tokyo Metropolitan Komagome Hospital
City
Bunkyo-ku
State/Province
Tokyo
Country
Japan
Facility Name
National Cancer Center Hospital
City
Chuo-ku
State/Province
Tokyo
Country
Japan
Facility Name
The Cancer Institute Hospital Of JFCR
City
Koto-ku
State/Province
Tokyo
Country
Japan
Facility Name
Tottori University Hospital
City
Yonago
State/Province
Tottori
Country
Japan
Facility Name
Akita University Hospital
City
Akita
Country
Japan
Facility Name
Aomori Prefectural Central Hospital
City
Aomori
Country
Japan
Facility Name
Chiba Cancer Center
City
Chiba
Country
Japan
Facility Name
Kyushu University Hospital
City
Fukuoka
Country
Japan
Facility Name
National Hospital Organization Kyushu Medical Center
City
Fukuoka
Country
Japan
Facility Name
Kagoshima University Hospital
City
Kagoshima
Country
Japan
Facility Name
National Hospital Organization Kumamoto Medical Center
City
Kumamoto
Country
Japan
Facility Name
Japanese Red Cross Kyoto Daini Hospital
City
Kyoto
Country
Japan
Facility Name
Okayama University Hospital
City
Okayama
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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