Clinical trial · Interventional
Study of ME-401 in Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma (NHL)
A Japanese Phase 2 Study of ME-401 in Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma (NHL)
NCT04533581CI-TRIAL-00094950active not recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Indolent B-cell Non-Hodgkin's Lymphoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ME-401 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ME-401
- interventionNames
- Drug: ME-401
Primary outcomes (1)
- measure
- Objective response rate (ORR)
- timeFrame
- Up to approximately 2 years
- description
- 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).
Secondary outcomes (8)
- measure
- Efficacy of ME-401 as assessed by the duration of response (DOR)
- timeFrame
- Up to approximately 4 years
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDMunakata 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