NCT04533581

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

A Japanese Phase 2 Study of ME-401 in Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma (NHL)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Kyowa Kirin Co., Ltd. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Indolent B-cell Non-Hodgkin's Lymphoma

Interventions

Type	Name	Description
DRUG	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).

Timeline

• Start date: 2020-09-17
• Primary completion: 2028-05-31
• Completion: 2028-05-31
• First posted: 2020-08-31
• Last updated: 2025-09-11

Locations

30 sites across 1 country: Japan