Study of ME-401 in Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma (NHL)
NCT ID: NCT04533581
Last Updated: 2025-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
61 participants
INTERVENTIONAL
2020-09-17
2028-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ME-401
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* 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 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
20 Years
ALL
No
Sponsors
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Kyowa Kirin Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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References
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Munakata W, Kumode T, Goto H, Fukuhara N, Shimoyama T, Takeuchi M, Kawakita T, Kubo K, Sawa M, Uchida T, Mishima Y, Ichii M, Hanaya M, Matsumoto A, Kuriki M, Seike T, Izutsu K, Ishizawa K. A phase II study of zandelisib in patients with relapsed or refractory indolent non-Hodgkin lymphoma: ME-401-K02 study. Br J Haematol. 2025 Feb;206(2):541-550. doi: 10.1111/bjh.19994. Epub 2025 Jan 8.
Other Identifiers
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ME-401-K02
Identifier Type: -
Identifier Source: org_study_id
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