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New pill shows promise for tough lymphoma in japanese study

NCT ID NCT04533581

Disease control Sponsor: Kyowa Kirin Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This phase 2 study tests an oral drug called ME-401 in 61 Japanese adults with a slow-growing form of non-Hodgkin's lymphoma that has returned or not responded to at least two prior treatments. The drug is taken daily for the first two months, then on a weekly schedule. Researchers are checking how well it shrinks tumors and how safe it is.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ME-401 (a PI3K inhibitor taken orally)
What this could lead to
If successful, this could provide a new treatment option for Japanese patients with a hard-to-treat form of lymphoma that has come back after other therapies.
What could go wrong
This is a small, early-phase study (61 people) with no comparison group. The drug may not work well enough or could cause side effects. It is also limited to Japanese patients, so results may not apply to other populations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

61 people

The number who actually took part.

Started

Sep 2020

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

indolent B-cell non-Hodgkin lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Indolent B-cell non-Hodgkin's lymphoma

Contacts and locations

Locations

  • Aichi Cancer Center Hospital

    Nagoya, Aichi-ken, Japan

  • Akita University Hospital

    Akita, Japan

  • Anjo Kosei Hospital

    Anjo, Aichi-ken, Japan

  • Aomori Prefectural Central Hospital

    Aomori, Japan

  • Chiba Cancer Center

    Chiba, Japan

  • Chugoku Central Hospital

    Fukuyama, Hiroshima, Japan

  • Gunma University Hospital

    Maebashi, Gunma, Japan

  • Hokkaido University Hospital

    Sapporo, Hokkaido, Japan

  • Ishikawa Prefectural Central Hospital

    Kanazawa, Ishikawa-ken, Japan

  • Japanese Red Cross Kyoto Daini Hospital

    Kyoto, Japan

  • Japanese Red Cross Nagoya Daini Hospital

    Nagoya, Aichi-ken, Japan

  • Jichi Medical University Hospital

    Shimotsuke, Tochigi, Japan

  • Kagoshima University Hospital

    Kagoshima, Japan

  • Kameda Medical Center

    Kamogawa, Chiba, Japan

  • Kindai University Hospital

    Sayama, Osaka, Japan

  • Kurashiki Central Hospital

    Kurashiki, Okayama-ken, Japan

  • Kyushu University Hospital

    Fukuoka, Japan

  • Mie University Hospital

    Tsu, Mie-ken, Japan

  • National Cancer Center Hospital

    Chuo-ku, Tokyo, Japan

  • National Hospital Organization Kumamoto Medical Center

    Kumamoto, Japan

  • National Hospital Organization Kyushu Medical Center

    Fukuoka, Japan

  • National Hospital Organization Nagoya Medical Center

    Nagoya, Aichi-ken, Japan

  • National Hospital Organization Shikoku Cancer Center

    Matsuyama, Ehime, Japan

  • Okayama University Hospital

    Okayama, Japan

  • Osaka University Hospital

    Suita, Osaka, Japan

  • Saitama Medical University International Medical Center

    Hidaka, Saitama, Japan

  • The Cancer Institute Hospital Of JFCR

    Koto-ku, Tokyo, Japan

  • Tohoku University Hospital

    Sendai, Miyagi, Japan

  • Tokyo Metropolitan Komagome Hospital

    Bunkyo-ku, Tokyo, Japan

  • Tottori University Hospital

    Yonago, Tottori, Japan

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