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Study of ME-401 in Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma (NHL)
Sponsor: Kyowa Kirin Co., Ltd.
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
Conditions
Interventions
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