Study of ME-401 in subjects with relapsed or refractory indolent B-cell non-Hodgkin's lymphoma and roll over study for subjects who have participated in ME-401-004 study
- Conditions
- B-cell non-Hodgkin`s lymphoma
- Registration Number
- JPRN-jRCT2080224714
- Lead Sponsor
- Kyowa Kirin Co., Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 14
- Patients aged 20 years or older at the submission of the written informed consent form
- Patients with relapsed or refractory B-cell NHL
- Patients who have not undergone phosphatidylinositol 3-kinase inhibitor (PI3K) to date.
- Patients who have undergone Bruton's tyrosine kinase (BTK) inhibitors and have had no exacerbation during the use of BTK inhibitors.
- Patients with ECOG PS 0 or 1.
- Patients who treated with ME-401 and acieved response of SD or better by IRRC tumor assessment in ME-401-004 study.
- Patients who underwent any major surgical treatment within 4 weeks prior to the initiation of the investigational product.
- Patients with poorly controlled diseases. The followings are the examples but the diseases will not be limited to those.
- Patients in whom any of HBV antigen/antibody, HCV antibody, HIV antibody or HTLV-1 antibody will be positive at screening test.
- Patients with active interstitial lung disease or a history thereof.
- Patients who have received the investigational products other than ME-401, systemic chemotherapy or radiotherapy within 4 weeks prior to the initiation of ME-401.
- Patients who have experienced adverse events related to ME-401 and been considered to be ineligible to participate in this study by physician.
- Patients with diseases not suitable for treatment with ME-401, for example, active interstitial lung disease and inflammatory bowel disease.
- Patients who have been treated or prevented CMV within the past 28 days.
- Patients who plan to participate in other clinical trials while receiving ME-401 in this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>- Adverse events<br>- Laboratory test values<br>- Vital signs<br>- Electrocardiogram (ECG) (To subjects for DLT evaluation)
- Secondary Outcome Measures
Name Time Method Pharmacokinetics (Subjects for DLT evaluation)<br>- Plasma concentration level of ME-401<br>- PK parameter<br><br>Efficacy (Subjects for DLT evaluation)<br>- Anti-tumor effect<br>- Duration of response (DOR)<br>- Progression-free survival (PFS)<br>- Time to response (TTR)