Clinical trial NCT04533581: Study of ME-401 in Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma (NHL)
Official title: A Japanese Phase 2 Study of ME-401 in Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma (NHL)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Indolent B-cell Non-Hodgkin's Lymphoma
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-08-31
Enrollment: 61
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 outcomes:
measure: Objective response rate (ORR)
timeFrame: Up to approximately 2 years
Secondary outcomes:
measure: Efficacy of ME-401 as assessed by the duration of response (DOR)
timeFrame: Up to approximately 4 years
measure: Efficacy of ME-401 as assessed by the progression-free survival (PFS)
timeFrame: Up to approximately 4 years
measure: Efficacy of ME-401 as assessed by CR
timeFrame: Up to approximately 4 years
measure: Efficacy of ME-401 as assessed by the Time to treatment failure (TTF)
timeFrame: Up to approximately 4 years
measure: Efficacy of ME-401 as assessed by the objective response rate (ORR)
timeFrame: Up to approximately 4 years
measure: Safety of ME-401 as assessed by the number of participants with treatment-emergent adverse events (TEAEs)
timeFrame: Up to approximately 4 years
measure: Safety of ME-401 as assessed by the time to occurrence of adverse event of special interest (AESI)
timeFrame: Up to approximately 4 years
measure: Plasma concentration level of ME-401
timeFrame: Up to approximately 4 years
Other outcomes:
Locations:
city: Anjo
country: Japan
facility: Anjo Kosei Hospital
state: Aichi
city: Nagoya
country: Japan
facility: Aichi Cancer Center Hospital
state: Aichi
city: Nagoya
country: Japan
facility: Japanese Red Cross Nagoya Daini Hospital
state: Aichi
city: Nagoya
country: Japan
facility: National Hospital Organization Nagoya Medical Center
state: Aichi
city: Kamogawa
country: Japan
facility: Kameda Medical Center
state: Chiba
city: Matsuyama
country: Japan
facility: National Hospital Organization Shikoku Cancer Center
state: Ehime
city: Maebashi
country: Japan
facility: Gunma University Hospital
state: Gunma
city: Fukuyama
country: Japan
facility: Chugoku Central Hospital
state: Hiroshima
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: Kanazawa
country: Japan
facility: Ishikawa Prefectural Central Hospital
state: Ishikawa
city: Tsu
country: Japan
facility: Mie University Hospital
state: Mie
city: Sendai
country: Japan
facility: Tohoku University Hospital
state: Miyagi
city: Kurashiki
country: Japan
facility: Kurashiki Central Hospital
state: Okayama
city: Osakasayama
country: Japan
facility: Kindai University Hospital
state: Osaka
city: Suita
country: Japan
facility: Osaka University Hospital
state: Osaka
city: Hidaka
country: Japan
facility: Saitama Medical University International Medical Center
state: Saitama
city: Shimotsuke
country: Japan
facility: Jichi Medical University Hospital
state: Tochigi
city: Bunkyo-ku
country: Japan
facility: Tokyo Metropolitan Komagome Hospital
state: Tokyo
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Koto-ku
country: Japan
facility: The Cancer Institute Hospital Of JFCR
state: Tokyo
city: Yonago
country: Japan
facility: Tottori University Hospital
state: Tottori
city: Akita
country: Japan
facility: Akita University Hospital
city: Aomori
country: Japan
facility: Aomori Prefectural Central Hospital
city: Chiba
country: Japan
facility: Chiba Cancer Center
city: Fukuoka
country: Japan
facility: Kyushu University Hospital
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Medical Center
city: Kagoshima
country: Japan
facility: Kagoshima University Hospital
city: Kumamoto
country: Japan
facility: National Hospital Organization Kumamoto Medical Center
city: Kyoto
country: Japan
facility: Japanese Red Cross Kyoto Daini Hospital
city: Okayama
country: Japan
facility: Okayama University Hospital
Study officials:
References: