Study of ME-401 in Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma (NHL)
- Conditions
- Indolent B-cell Non-Hodgkin's Lymphoma
- Interventions
- Registration Number
- NCT04533581
- Lead Sponsor
- Kyowa Kirin Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 61
- 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"
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ME-401 ME-401 -
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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 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 time to occurrence of adverse event of special interest (AESI) Up to approximately 4 years Efficacy of ME-401 as assessed by CR 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 Plasma concentration level of ME-401 Up to approximately 4 years Efficacy of ME-401 as assessed by the Time to treatment failure (TTF) Up to approximately 4 years
Trial Locations
- 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
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