Study of ME-401 in Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma (NHL) (NCT04533581) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Study of ME-401 in Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma (NHL)
Japan61 participantsStarted 2020-09-17
Plain-language 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.
Who can participate
Age range20 Years
SexALL
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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