Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in Japan / NCT04533581
Active, not recruiting Phase 2

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

NCT04533581 · tracked via the Priya Life Science Japan tracker
Sponsor
Kyowa Kirin Co., Ltd
Phase
Phase 2
Started
2020-09-17
Last updated
2026-10-05

Condition(s) studied

Indolent B-cell Non-Hodgkin's Lymphoma

Investigational drug(s) / intervention(s)

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).

Study 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.

Eligibility

Sex
ALL
Min age
20 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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" Exclusion Criteria: * 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

Primary outcome measure(s)

  • 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).

Trial sites (30)

FacilityCityRegionStatus
Anjo Kosei Hospital Anjo Aichi-ken
Aichi Cancer Center Hospital Nagoya Aichi-ken
Japanese Red Cross Nagoya Daini Hospital Nagoya Aichi-ken
National Hospital Organization Nagoya Medical Center Nagoya Aichi-ken
Kameda Medical Center Kamogawa Chiba
National Hospital Organization Shikoku Cancer Center Matsuyama Ehime
Gunma University Hospital Maebashi Gunma
Chugoku Central Hospital Fukuyama Hiroshima
Hokkaido University Hospital Sapporo Hokkaido
Ishikawa Prefectural Central Hospital Kanazawa Ishikawa-ken
Mie University Hospital Tsu Mie-ken
Tohoku University Hospital Sendai Miyagi
Kurashiki Central Hospital Kurashiki Okayama-ken
Kindai University Hospital Sayama Osaka
Osaka University Hospital Suita Osaka
Saitama Medical University International Medical Center Hidaka Saitama
Jichi Medical University Hospital Shimotsuke Tochigi
Tokyo Metropolitan Komagome Hospital Bunkyo-ku Tokyo
National Cancer Center Hospital Chuo-ku Tokyo
The Cancer Institute Hospital Of JFCR Koto-ku Tokyo
Tottori University Hospital Yonago Tottori
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

More Kyowa Kirin Co., Ltd. trials in Japan

Evaluate the Efficacy and Safety of KK8398 in Patients With Achondroplasia（AOBA Study） Active, not recruiting
A Clinical Study of KK2260 in Patients With Advanced or Metastatic Solid Tumors Recruiting
A Phase 2 Clinical Study of Ziftomenib in Patients With Relapsed or Refractory NPM1-Mutated Acute Myeloid Leukemia Recruiting
Phase I Clinical Trial of KK2845 in Patients With Relapsed or Refractory Acute Myeloid Leukemia and Other Hematologic Malignancies. Recruiting
Study of KK3910 in Healthy Volunteers and Patients With Essential Hypertension Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04533581 on ClinicalTrials.gov ↗ ← All trials in Japan