Clincosm LogoSign in Get a demo

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

Sponsor
Kyowa Kirin Co., Ltd. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04533581
Collaborator
(none)
61
Enrollment
30
Locations
1
Arm
48.4
Anticipated Duration (Months)
2
Patients Per Site
0
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
61 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Japanese Phase 2 Study of ME-401 in Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma (NHL)
Actual Study Start Date :
Sep 17, 2020
Anticipated Primary Completion Date :
Sep 30, 2024
Anticipated Study Completion Date :
Sep 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: ME-401

Drug: ME-401
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).

Outcome Measures

Primary Outcome Measures

  1. Objective response rate (ORR) [Up to approximately 2 years]

    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

  1. Efficacy of ME-401 as assessed by the duration of response (DOR) [Up to approximately 4 years]

  2. Efficacy of ME-401 as assessed by the progression-free survival (PFS) [Up to approximately 4 years]

  3. Efficacy of ME-401 as assessed by CR [Up to approximately 4 years]

  4. Efficacy of ME-401 as assessed by the Time to treatment failure (TTF) [Up to approximately 4 years]

  5. Efficacy of ME-401 as assessed by the objective response rate (ORR) [Up to approximately 4 years]

  6. Safety of ME-401 as assessed by the number of participants with treatment-emergent adverse events (TEAEs) [Up to approximately 4 years]

  7. Safety of ME-401 as assessed by the time to occurrence of adverse event of special interest (AESI) [Up to approximately 4 years]

  8. Plasma concentration level of ME-401 [Up to approximately 4 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Anjo Kosei Hospital Anjo Aichi Japan
2 Aichi Cancer Center Hospital Nagoya Aichi Japan
3 Japanese Red Cross Nagoya Daini Hospital Nagoya Aichi Japan
4 National Hospital Organization Nagoya Medical Center Nagoya Aichi Japan
5 Kameda Medical Center Kamogawa Chiba Japan
6 National Hospital Organization Shikoku Cancer Center Matsuyama Ehime Japan
7 Gunma University Hospital Maebashi Gunma Japan
8 Chugoku Central Hospital Fukuyama Hiroshima Japan
9 Hokkaido University Hospital Sapporo Hokkaido Japan
10 Ishikawa Prefectural Central Hospital Kanazawa Ishikawa Japan
11 Mie University Hospital Tsu Mie Japan
12 Tohoku University Hospital Sendai Miyagi Japan
13 Kurashiki Central Hospital Kurashiki Okayama Japan
14 Kindai University Hospital Osakasayama Osaka Japan
15 Osaka University Hospital Suita Osaka Japan
16 Saitama Medical University International Medical Center Hidaka Saitama Japan
17 Jichi Medical University Hospital Shimotsuke Tochigi Japan
18 Tokyo Metropolitan Komagome Hospital Bunkyo-ku Tokyo Japan
19 National Cancer Center Hospital Chuo-ku Tokyo Japan
20 The Cancer Institute Hospital Of JFCR Koto-ku Tokyo Japan
21 Tottori University Hospital Yonago Tottori Japan
22 Akita University Hospital Akita Japan
23 Aomori Prefectural Central Hospital Aomori Japan
24 Chiba Cancer Center Chiba Japan
25 Kyushu University Hospital Fukuoka Japan
26 National Hospital Organization Kyushu Medical Center Fukuoka Japan
27 Kagoshima University Hospital Kagoshima Japan
28 National Hospital Organization Kumamoto Medical Center Kumamoto Japan
29 Japanese Red Cross Kyoto Daini Hospital Kyoto Japan
30 Okayama University Hospital Okayama Japan

Sponsors and Collaborators

  • Kyowa Kirin Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kyowa Kirin Co., Ltd.
ClinicalTrials.gov Identifier:
NCT04533581
Other Study ID Numbers:
  • ME-401-K02
First Posted:
Aug 31, 2020
Last Update Posted:
Dec 27, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell

Study Results

No Results Posted as of Dec 27, 2021