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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ME-401 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ME-401 | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of ME-401 as assessed by the duration of response (DOR) | Up to approximately 4 years | |
| Efficacy of ME-401 as assessed by the progression-free survival (PFS) | Up to approximately 4 years | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anjo Kosei Hospital | Anjo | Aichi-ken | Japan | |||
| Aichi Cancer Center Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39778876 | Derived | 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. |
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|
| Efficacy of ME-401 as assessed by CR |
| Up to approximately 4 years |
| Efficacy of ME-401 as assessed by the Time to treatment failure (TTF) | Up to approximately 4 years |
| Efficacy of ME-401 as assessed by the objective response rate (ORR) | Up to approximately 4 years |
| Safety of ME-401 as assessed by the number of participants with treatment-emergent adverse events (TEAEs) | Up to approximately 4 years |
| Safety of ME-401 as assessed by the time to occurrence of adverse event of special interest (AESI) | Up to approximately 4 years |
| Plasma concentration level of ME-401 | Up to approximately 4 years |
| 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 |
| ID | Term |
|---|---|
| C000654193 | ME-401 |
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