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ACTIVE NOT RECRUITING
NCT04533581
PHASE2

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

Sponsor: Kyowa Kirin Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: A Japanese Phase 2 Study of ME-401 in Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma (NHL)

Key Details

Gender

All

Age Range

20 Years - Any

Study Type

INTERVENTIONAL

Enrollment

61

Start Date

2020-09-17

Completion Date

2028-05-31

Last Updated

2025-09-11

Healthy Volunteers

No

Interventions

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).

Locations (30)

Anjo Kosei Hospital

Anjo, Aichi-ken, Japan

Aichi Cancer Center Hospital

Nagoya, Aichi-ken, Japan

Japanese Red Cross Nagoya Daini Hospital

Nagoya, Aichi-ken, Japan

National Hospital Organization Nagoya Medical Center

Nagoya, Aichi-ken, Japan

Kameda Medical Center

Kamogawa, Chiba, Japan

National Hospital Organization Shikoku Cancer Center

Matsuyama, Ehime, Japan

Gunma University Hospital

Maebashi, Gunma, Japan

Chugoku Central Hospital

Fukuyama, Hiroshima, Japan

Hokkaido University Hospital

Sapporo, Hokkaido, Japan

Ishikawa Prefectural Central Hospital

Kanazawa, Ishikawa-ken, Japan

Mie University Hospital

Tsu, Mie-ken, Japan

Tohoku University Hospital

Sendai, Miyagi, Japan

Kurashiki Central Hospital

Kurashiki, Okayama-ken, Japan

Kindai University Hospital

Sayama, Osaka, Japan

Osaka University Hospital

Suita, Osaka, Japan

Saitama Medical University International Medical Center

Hidaka, Saitama, Japan

Jichi Medical University Hospital

Shimotsuke, Tochigi, Japan

Tokyo Metropolitan Komagome Hospital

Bunkyo-ku, Tokyo, Japan

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan

The Cancer Institute Hospital Of JFCR

Koto-ku, Tokyo, Japan

Tottori University Hospital

Yonago, Tottori, Japan

Akita University Hospital

Akita, Japan

Aomori Prefectural Central Hospital

Aomori, Japan

Chiba Cancer Center

Chiba, Japan

Kyushu University Hospital

Fukuoka, Japan

National Hospital Organization Kyushu Medical Center

Fukuoka, Japan

Kagoshima University Hospital

Kagoshima, Japan

National Hospital Organization Kumamoto Medical Center

Kumamoto, Japan

Japanese Red Cross Kyoto Daini Hospital

Kyoto, Japan

Okayama University Hospital

Okayama, Japan