Indolent B-cell Non-Hodgkin's Lymphoma
Conditions
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.
Interventions
DRUGME-401
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).
Sponsors
Kyowa Kirin Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) | 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). |
Secondary
| Measure | Time frame |
|---|---|
| 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 duration of response (DOR) | Up to approximately 4 years |
| Safety of ME-401 as assessed by the number of participants with treatment-emergent adverse events (TEAEs) | Up to approximately 4 years |
| Safety of ME-401 as assessed by the time to occurrence of adverse event of special interest (AESI) | Up to approximately 4 years |
| Plasma concentration level of ME-401 | Up to approximately 4 years |
| Efficacy of ME-401 as assessed by the objective response rate (ORR) | Up to approximately 4 years |
Countries
Japan
Outcome results
None listed