Indolent B-cell Non-Hodgkin's Lymphoma (NHL)
Conditions
Interventions
investigational material(s)
Generic name etc : ME-401
INN of investigational material : -
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material
Sponsors
Kyowa Kirin Co., Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients with relapsed or refractory B-cell NHL who is categorized into SLL, WM, LPL by WHO classification - Patients who have been histologically confirmed FL Grade 3b transformation from 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
Exclusion criteria
Exclusion criteria: - Patients with relapsed or refractory B-cell NHL who is categorized into SLL, WM, LPL by WHO classification - Patients who have been histologically confirmed FL Grade 3b transformation from 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 |
|---|---|
| efficacy Best response | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy - Duration of response (DOR) - Progression-free survival (PFS) - Complete response (CR) - Time to treatment failure (TTF) safety - Adverse events (AE) - Laboratory test values - Vital signs - Electrocardiogram (ECG) - Adverse events of special interest (AESI) - Time to occurrence of AESI pharmacokinetics Plasma concentration level of ME-401 | — |
Countries
Japan
Outcome results
None listed