Follicular lymphoma (FL) MedDRA version: 20.0 Level: LLT Classification code 10029473 Term: Nodular (follicular) lymphoma System Organ Class: 100000004864
Conditions
Interventions
Product Code: ME-401
Pharmaceutical Form: Capsule
INN or Proposed INN: ME-401
CAS Number: 1401436-95-0
Current Sponsor code: ME-401
Other descriptive name: ME-401
Concentration unit: mg milligram(s)
C
Sponsors
MEI Pharma, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age = 18 years (or age of majority) 2. Histologically confirmed diagnosis of FL as defined in the WHO classification scheme, limited to Grade 1, 2, or 3a 3. Progression of disease after at least 2 prior systemic therapies for FL. Subjects must have received an anti-CD20 antibody (minimum of 4 doses) and chemotherapy (minimum of 2 doses, which must have included an alkylating agent or a purine analogue), whether administered together or as successive treatments; radioimmunotherapy, high dose therapy and autologous stem cell transplantation, and CAR T-cell therapy are considered as one line of therapy Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 115 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: 1. Known active histological transformation from FL to an aggressive lymphoma: biopsy documentation of the absence or presence of transformation is not required and left to the Investigator’s discretion 2. Major surgical procedure within 4 weeks of Day 1 3. Any uncontrolled clinically significant illness including, but not limited to, active infections, hypertension, angina, arrhythmias, pulmonary disease, or autoimmune dysfunction 4. Subjects who have tested positive for hepatitis B surface antigen and/or hepatitis B core antibody plus have a positive hepatitis B PCR assay; subjects with a negative PCR assay are permitted with appropriate anti-viral prophylaxis 5. Positive HCV Ab; subjects with positive hepatitis C antibody are eligible if they are negative for HCV by PCR 6. Ongoing or history of drug-induced pneumonitis 7. Other diagnosis of cancer that is likely to require treatment in the next 2 years, with the exception of the following: a. Curatively treated basal cell carcinoma or squamous cell carcinoma of the skin b. Curatively treated carcinoma in situ of the cervix c. Hormonal therapy for prostate cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To evaluate the objective response rate (ORR) of ME-401 in relapsed FL, defined as the best response rating of complete response (CR) or partial response (PR) according to the Lugano Response Criteria , as determined by an Independent Response Review Committee (IRRC) 2. To evaluate the tolerability of ME-401, defined as the rate of AEs requiring modified dosing schedule or study drug discontinuation (AERDM);Secondary Objective: 1. To evaluate the efficacy of ME-401 as assessed by an IRRC: o Duration of response (DOR) among subjects with an objective response o Complete response (CR) rate o Progression-free survival (PFS) 2.To evaluate the efficacy of ME-401 as assessed by the Investigator: o Objective response rate (ORR) o Duration of response (DOR) among subjects with an objective response o Complete response (CR) rate o Progression-free survival (PFS) 3.To evaluate overall survival (OS) 4.To evaluate the safety profile of ME-401 o Overall incidence of AEs o Time to occurrence of AERDM 5.To evaluate the PK of ME-401;Primary end point(s): The primary endpoints are: 1) ORR defined as the best response of CR + PR as determined by an IRRC, and 2) the proportion of subjects requiring a modified dosing schedule or study drug discontinuation for CTCAE v5.0 Grade = 2 AEs thought to be related or possibly related to the study drug.;Timepoint(s) of evaluation of this end point: TBC: 1. meetings by IRRC for ORR 2. After the last patient has been on the study for 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Duration of Response (DOR) DOR will be evaluated as a secondary endpoint and is defined as time from documentation of the first CR or PR to the time of disease progression or relapse (based on the Lugano Response Criteria) independently from study period or dosing schedule. 2.Progression-Free Survival (PFS) PFS will be assessed as a secondary endpoint and is defined as time from initiation of treatment (Day 1) until disease progression or death from any cause independently from the study period or dosing schedule. PFS time will be censored at the last disease assessment date indicating the absence of progression or recurrence for subjects who have not demonstrated objective progression and are still alive. For subjects who withdraw consent for any reason before demonstrating evidence of progression or recurrence, PFS time will be censored at the last date for which disease assessment indicated the absence of progression or recurrence. Subjects are censored at the date of first dose of study treatment if no additional follow-up data are obtained. 3. Overall Survival (OS) OS will be assessed as a secondary endpoint and is defined as time from initiation of treatment (Day 1) until death from any cause independently from the study period or dosing schedule. OS time will be censored at the last date the subject is known to be alive when the confirmation of death is absent or unknown.;Timepoint(s) of evaluation of this end point: After the last patient has been on the study for 6 months. | — |
Countries
Australia, Austria, Belgium, Canada, France, Germany, Italy, Korea, Republic of, New Zealand, Poland, Spain, Switzerland, Taiwan, United Kingdom, United States
Contacts
Public ContactErika Coleman
MEI Pharma Inc
Outcome results
None listed