Indolent B-cell Non-Hodgkin's LymphomaPhase 2NCT04533581
Study of ME-401 in Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma (NHL)
A Phase 2 study testing ME-401 in people with Indolent B-cell Non-Hodgkin's Lymphoma, run by Kyowa Kirin Co., Ltd. at 30 sites in Japan.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Indolent B-cell Non-Hodgkin's Lymphoma
- What is being tested?
- ME-401
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 30 sitesJapan
- Study dates
- 17 Sep 2020to 31 May 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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"
Who cannot join
- 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
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
Japan30 sites
Akita University Hospital
Akita
Anjo Kosei Hospital
Anjo, Aichi-ken
Aomori Prefectural Central Hospital
Aomori
Tokyo Metropolitan Komagome Hospital
Bunkyo-ku, Tokyo
Chiba Cancer Center
Chiba
National Cancer Center Hospital
Chuo-ku, Tokyo
Kyushu University Hospital
Fukuoka
National Hospital Organization Kyushu Medical Center
Fukuoka
Chugoku Central Hospital
Fukuyama, Hiroshima
Saitama Medical University International Medical Center
Hidaka, Saitama
Kagoshima University Hospital
Kagoshima
Kameda Medical Center
Kamogawa, Chiba
Ishikawa Prefectural Central Hospital
Kanazawa, Ishikawa-ken
The Cancer Institute Hospital Of JFCR
Koto-ku, Tokyo
National Hospital Organization Kumamoto Medical Center
Kumamoto
Kurashiki Central Hospital
Kurashiki, Okayama-ken
Japanese Red Cross Kyoto Daini Hospital
Kyoto
Gunma University Hospital
Maebashi, Gunma
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime
Aichi Cancer Center Hospital
Nagoya, Aichi-ken
Japanese Red Cross Nagoya Daini Hospital
Nagoya, Aichi-ken
National Hospital Organization Nagoya Medical Center
Nagoya, Aichi-ken
Okayama University Hospital
Okayama
Hokkaido University Hospital
Sapporo, Hokkaido
Kindai University Hospital
Sayama, Osaka
Tohoku University Hospital
Sendai, Miyagi
Jichi Medical University Hospital
Shimotsuke, Tochigi
Osaka University Hospital
Suita, Osaka
Mie University Hospital
Tsu, Mie-ken
Tottori University Hospital
Yonago, Tottori
About this study
Official title: A Japanese Phase 2 Study of ME-401 in Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma (NHL)
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
- Being tested
- ME-401
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ME-401Drug
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).
| Study group | Role | What they receive |
|---|---|---|
| ME-401 | Experimental | Not described Receives: Drug: ME-401 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to approximately 2 years
Secondary outcomes (8)
Efficacy of ME-401 as assessed by the duration of response (DOR)
Measured: Up to approximately 4 years
Efficacy of ME-401 as assessed by the progression-free survival (PFS)
Measured: Up to approximately 4 years
Efficacy of ME-401 as assessed by CR
Measured: Up to approximately 4 years
Efficacy of ME-401 as assessed by the Time to treatment failure (TTF)
Measured: Up to approximately 4 years
Efficacy of ME-401 as assessed by the objective response rate (ORR)
Measured: Up to approximately 4 years
Safety of ME-401 as assessed by the number of participants with treatment-emergent adverse events (TEAEs)
Measured: Up to approximately 4 years
Safety of ME-401 as assessed by the time to occurrence of adverse event of special interest (AESI)
Measured: Up to approximately 4 years
Plasma concentration level of ME-401
Measured: Up to approximately 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2020
- Study start17 Sep 2020
- Primary completion31 May 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Indolent B-cell Non-Hodgkin's LymphomaStudies of the same condition, open and under way.
- More trials run by Kyowa Kirin Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyowa Kirin Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04533581
- Sponsor's protocol ID
- ME-401-K02
- Status last verified
- Oct 2026
- First submitted
- 26 Aug 2020
- Last updated
- 5 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39778876
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Japanese Phase 2 Study of ME-401 in Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma (NHL)
- ClinicalTrials.gov ID
- NCT04533581
- Acronym / sponsor ID
- ME-401-K02
- Conditions
- Indolent B-cell Non-Hodgkin's Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Sep 2020 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 31 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ME-401 | Experimental | Drug: ME-401 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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"
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ME-401In 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). | Drug | ME-401 |
Primary outcome
Objective response rate (ORR)
Time frame: Up to approximately 2 years
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).
8 secondary outcomes
Efficacy of ME-401 as assessed by the duration of response (DOR)
Time frame: Up to approximately 4 years
Efficacy of ME-401 as assessed by the progression-free survival (PFS)
Time frame: Up to approximately 4 years
Efficacy of ME-401 as assessed by CR
Time frame: Up to approximately 4 years
Efficacy of ME-401 as assessed by the Time to treatment failure (TTF)
Time frame: Up to approximately 4 years
Efficacy of ME-401 as assessed by the objective response rate (ORR)
Time frame: Up to approximately 4 years
Safety of ME-401 as assessed by the number of participants with treatment-emergent adverse events (TEAEs)
Time frame: Up to approximately 4 years
Safety of ME-401 as assessed by the time to occurrence of adverse event of special interest (AESI)
Time frame: Up to approximately 4 years
Plasma concentration level of ME-401
Time frame: Up to approximately 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Derived from this study: PubMed 39778876Munakata 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ME-401 in people with Indolent B-cell Non-Hodgkin's Lymphoma, run by Kyowa Kirin Co., Ltd. at 30 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: Up to approximately 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04533581, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.