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

NCT04533581 | Active Not Recruiting Phase 2

• 1 other identifier: ME-401-K02
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 30

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.

Conditions

Indolent B-cell Non-Hodgkin's Lymphoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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 CR

  Up to approximately 4 years

• Efficacy of ME-401 as assessed by the Time to treatment failure (TTF)

  Up to approximately 4 years

• Efficacy of ME-401 as assessed by the objective response rate (ORR)

  Up to approximately 4 years

Study Arms (1)

ME-401

EXPERIMENTAL

Drug: ME-401

Interventions

ME-401 DRUG

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).

ME-401

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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"

You may not qualify if:

• 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

Sponsors & Collaborators

• Kyowa Kirin Co., Ltd.: lead

Study Sites (30)

Anjo Kosei Hospital

Anjo, Aichi-ken, Japan

Location

Aichi Cancer Center Hospital

Nagoya, Aichi-ken, Japan

Location

Japanese Red Cross Nagoya Daini Hospital

Nagoya, Aichi-ken, Japan

Location

National Hospital Organization Nagoya Medical Center

Nagoya, Aichi-ken, Japan

Location

Kameda Medical Center

Kamogawa, Chiba, Japan

Location

National Hospital Organization Shikoku Cancer Center

Matsuyama, Ehime, Japan

Location

Gunma University Hospital

Maebashi, Gunma, Japan

Location

Chugoku Central Hospital

Fukuyama, Hiroshima, Japan

Location

Hokkaido University Hospital

Sapporo, Hokkaido, Japan

Location

Ishikawa Prefectural Central Hospital

Kanazawa, Ishikawa-ken, Japan

Location

Mie University Hospital

Tsu, Mie-ken, Japan

Location

Tohoku University Hospital

Sendai, Miyagi, Japan

Location

Kurashiki Central Hospital

Kurashiki, Okayama-ken, Japan

Location

Kindai University Hospital

Sayama, Osaka, Japan

Location

Osaka University Hospital

Suita, Osaka, Japan

Location

Saitama Medical University International Medical Center

Hidaka, Saitama, Japan

Location

Jichi Medical University Hospital

Shimotsuke, Tochigi, Japan

Location

Tokyo Metropolitan Komagome Hospital

Bunkyo-ku, Tokyo, Japan

Location

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan

Location

The Cancer Institute Hospital Of JFCR

Koto-ku, Tokyo, Japan

Location

Tottori University Hospital

Yonago, Tottori, Japan

Location

Akita University Hospital

Akita, Japan

Location

Aomori Prefectural Central Hospital

Aomori, Japan

Location

Chiba Cancer Center

Chiba, Japan

Location

Kyushu University Hospital

Fukuoka, Japan

Location

National Hospital Organization Kyushu Medical Center

Fukuoka, Japan

Location

Kagoshima University Hospital

Kagoshima, Japan

Location

National Hospital Organization Kumamoto Medical Center

Kumamoto, Japan

Location

Japanese Red Cross Kyoto Daini Hospital

Kyoto, Japan

Location

Okayama University Hospital

Okayama, Japan

Location

Related Publications (1)

• Munakata W, Kumode T, Goto H, Fukuhara N, Shimoyama T, Takeuchi M, Kawakita T, Kubo K, Sawa M, Uchida T, Mishima Y, Ichii M, Hanaya M, Matsumoto A, Kuriki M, Seike T, Izutsu K, Ishizawa K. A phase II study of zandelisib in patients with relapsed or refractory indolent non-Hodgkin lymphoma: ME-401-K02 study. Br J Haematol. 2025 Feb;206(2):541-550. doi: 10.1111/bjh.19994. Epub 2025 Jan 8.

  PMID: 39778876 DERIVED

MeSH Terms

Interventions

ME-401

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: August 31, 2020
• Study Start: September 17, 2020
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2028
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

JP (30)