Phase 2 Study of ME-401 in Subjects with Follicular Lymphoma

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 0

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. Subjects with relapsed or refractory FL who received =2 prior therapy regimens. A previous regimen is defined as one of the following: at least two months of single-agent therapy or at least two consecutive cycles of polychemotherapy, autologous transplant, or radioimmunotherapy. Prior therapy must include rituximab and an alkylating agent(s). Relapsed or refractory disease defined as:
a. Relapsed disease: disease progression after a response (CR or PR) lasting =6 months
b. Refractory disease: no response to therapy (no CR or PR) or response lasting <6 months
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 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

1. Histologically confirmed FL Grade 3b, or transformed disease (assessed by the Investigator):
a. Histological confirmation of transformation, or
b. Clinical and laboratory signs: rapid disease progression, high standardized uptake value (>12) by positron emission tomography (PET) at baseline
2. Known lymphomatous involvement of the central nervous system.
3. Major surgical procedure within 4 weeks prior to study Day 1
4. Prior therapy with PI3K inhibitors.
5. Any uncontrolled clinically significant illness including, but not limited to, active infections requiring systemic antimicrobial therapy, hypertension, angina, arrhythmias, pulmonary disease, or autoimmune dysfunction
6. 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
7. Positive HCV Ab; subjects with positive hepatitis C antibody are eligible if they are negative for HCV by PCR.
8. Known history of, or active HIV infection.
9. Ongoing or history of drug-induced pneumonitis
10. Previous or concurrent cancer that is distinct in primary site or histology from indolent B-cell NHL within 3 years before start of study treatment except for curatively treated cervical cancer in situ, nonmelanoma skin cancer, and superficial bladder tumors (Ta [non-invasive tumor], Tis [carcinoma in situ], and T1 [tumor invades lamina propria]).
11. History of clinically significant cardiovascular abnormalities such as congestive heart failure (New York Heart Association classification = II [NYHA 1994]), myocardial infarction within 6 months of study entry.
12. History of clinically significant gastrointestinal (GI) conditions, particularly:
a. Known GI condition that would interfere with swallowing or the oral absorption or tolerance of study drug
b. Pre-existing malabsorption syndrome or other clinical situation that would affect oral absorption
13. Females who are pregnant; females who plan to breastfeed during study treatment through 90 days after ending treatment.
14. Psychiatric illness/social situations that would interfere with study compliance.
15. Hypersensitivity or other clinically significant reaction to the study drug or its inactive ingredients.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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