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

Indolent B-cell Non-Hodgkin's Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04533581
• Other study ID #: ME-401-K02
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: September 17, 2020
• Est. completion date: September 30, 2024

Study information

• Verified date: August 2023
• Source: Kyowa Kirin Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 61
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Indolent B-cell Non-Hodgkin's Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Non-Hodgkin

Intervention

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).

Locations

Country	Name	City	State
Japan	Akita University Hospital	Akita
Japan	Anjo Kosei Hospital	Anjo	Aichi
Japan	Aomori Prefectural Central Hospital	Aomori
Japan	Tokyo Metropolitan Komagome Hospital	Bunkyo-ku	Tokyo
Japan	Chiba Cancer Center	Chiba
Japan	National Cancer Center Hospital	Chuo-ku	Tokyo
Japan	Kyushu University Hospital	Fukuoka
Japan	National Hospital Organization Kyushu Medical Center	Fukuoka
Japan	Chugoku Central Hospital	Fukuyama	Hiroshima
Japan	Saitama Medical University International Medical Center	Hidaka	Saitama
Japan	Kagoshima University Hospital	Kagoshima
Japan	Kameda Medical Center	Kamogawa	Chiba
Japan	Ishikawa Prefectural Central Hospital	Kanazawa	Ishikawa
Japan	The Cancer Institute Hospital Of JFCR	Koto-ku	Tokyo
Japan	National Hospital Organization Kumamoto Medical Center	Kumamoto
Japan	Kurashiki Central Hospital	Kurashiki	Okayama
Japan	Japanese Red Cross Kyoto Daini Hospital	Kyoto
Japan	Gunma University Hospital	Maebashi	Gunma
Japan	National Hospital Organization Shikoku Cancer Center	Matsuyama	Ehime
Japan	Aichi Cancer Center Hospital	Nagoya	Aichi
Japan	Japanese Red Cross Nagoya Daini Hospital	Nagoya	Aichi
Japan	National Hospital Organization Nagoya Medical Center	Nagoya	Aichi
Japan	Okayama University Hospital	Okayama
Japan	Kindai University Hospital	Osakasayama	Osaka
Japan	Hokkaido University Hospital	Sapporo	Hokkaido
Japan	Tohoku University Hospital	Sendai	Miyagi
Japan	Jichi Medical University Hospital	Shimotsuke	Tochigi
Japan	Osaka University Hospital	Suita	Osaka
Japan	Mie University Hospital	Tsu	Mie
Japan	Tottori University Hospital	Yonago	Tottori

Sponsors (1)

Lead Sponsor	Collaborator
Kyowa Kirin Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Efficacy of ME-401 as assessed by the duration of response (DOR)		Up to approximately 4 years
Secondary	Efficacy of ME-401 as assessed by the progression-free survival (PFS)		Up to approximately 4 years
Secondary	Efficacy of ME-401 as assessed by CR		Up to approximately 4 years
Secondary	Efficacy of ME-401 as assessed by the Time to treatment failure (TTF)		Up to approximately 4 years
Secondary	Efficacy of ME-401 as assessed by the objective response rate (ORR)		Up to approximately 4 years
Secondary	Safety of ME-401 as assessed by the number of participants with treatment-emergent adverse events (TEAEs)		Up to approximately 4 years
Secondary	Safety of ME-401 as assessed by the time to occurrence of adverse event of special interest (AESI)		Up to approximately 4 years
Secondary	Plasma concentration level of ME-401		Up to approximately 4 years