A phase 2 clinical trial designed to investigate the safety and effectiveness of the investigational product Abexinostat, in patients with relapsed or refractory Follicular Lymphoma.All subjects will receive the study drug Abexinostat.
- Conditions
- Follicular LynphomaMedDRA version: 21.0Level: LLTClassification code 10059433Term: Follicular mixed small and large cell lymphoma recurrentSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2018-001701-82-IT
- Lead Sponsor
- Xynomic Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 139
Each patient must meet all of the following criteria to be enrolled in this
study:
1. Is male or female aged 18 years or older
2. Is able to understand and voluntarily sign an informed consent document before any study related assessments/procedures are conducted
3. Has histologically confirmed Grade 1, 2, or 3a follicular lymphoma
4. Has undergone at least 3 prior systemic lines of therapy for their follicular lymphoma, which included an anti-CD20 antibody and cytotoxic therapy
5. Has follicular lymphoma that has relapsed after (progressed after 6 months from the start of therapy) or is refractory to the last line of therapy (no response or progression within 6 months from the start of therapy) and needs treatment (must have at least 1 lymph node or extranodal lymphoid malignancy measuring = 3 cm in its longest diameter)
6. Has radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of = 1 lesion that measures = 3 cm in the longest diameter) as assessed by computed tomography or magnetic resonance imaging
7. Has Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
8. Has adequate hematologic function as defined by:
a. Absolute neutrophil count > x1E+09
b. Hemoglobin = 8 g/dL
c. Platelet count > 75 ×1E+09
9. Has adequate renal function as defined by creatinine clearance = 30 mL/min
10. Has adequate hepatic function as defined by:
a. AST and ALT < 1.5 × upper limit of normal (ULN)
b. Total bilirubin < 1.5 × ULN
11. Female patients must fulfil the following criteria:
a. Be of non-childbearing potential, defined as follows:
i. Postmenopausal (ie, = 1 year without any menses) prior to Screening,
or
ii. Documented surgically sterile (= 1 month prior to Screening)
b. If of childbearing potential:
i. Agree not to try to become pregnant during the study and for 90 days
after the last dose
ii. Have a negative pregnancy test at Screening, and
iii. If heterosexually active, agree to consistently use 2 different forms of highly effective birth control (at least 1 of which must be a barrier method) starting at Screening and continuing throughout the study until after 90 days after the last dose
c. Use highly effective forms of birth control (women of childbearing potential only), which include the following:
i. Consistent and correct use of established oral contraception
ii. Established intrauterine device or intrauterine system
iii. Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository
12. Female patients must agree not to breastfeed starting from the time of Screening, throughout the study, and until after 90 days following the last dose
13. Male patients and their female spouse/partners who are of childbearing potential must use highly effective contraception methods consisting of 2 forms of birth control (at least 1 of which must be a barrier method) from the time of Screening, throughout the study, and until after 90 days following the last dose
14. Male patients must agree not to donate sperm starting from the time of Screening, throughout the study, and until after 90 days following the last dose
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 95
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 44
Patients meeting any of the following criteria will be excluded from the study:
1. Has histologically confirmed diagnosis of Grade 3b follicular lymphoma, or transformation to diffuse large B cell lymphoma. In patients with clinical suspicion of transformed disease, a fresh biopsy is recommended.
2. Has a history of central nervous system lymphoma (either primary or secondary).
3. Has had prior treatment with abexinostat.
4. Has had allogeneic stem cell transplant within the last 6 months, or autologous stem cell transplant within the last 3 months before enrollment.
5. Has active graft-versus-host disease.
6. Has used prohibited medication (Section 5.7 and Section 5.8) within 7 days or 5 half-lives, whichever is shorter, prior to first dose of study drug.
7. Has evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection or risk of reactivation: HBV DNA and HCV RNA must be undetectable. Patients cannot be positive for hepatitis B surface antigen (HBsAg) or anti hepatitis B core antibody. Patients who have positive antibodies against HBsAg as the only evidence of prior exposure may participate in the study provided that there is both:
a. no known history of HBV infection, and
b. verified receipt of hepatitis B vaccine
8. Is taking corticosteroids during the last 1 week prior to Cycle 1 Day 1, unless administered at a dose equivalent to < 20 mg/day prednisone (over this 1 week).
9. Has not recovered from a major surgical intervention.
10. Is a female who is currently pregnant, breastfeeding, or planning to become pregnant or to breastfeed within 90 days of the last dose of study drug.
11. Has any of the following types of cardiac impairment at the time of enrollment:
a. New York Heart Association Class III or IV heart disease
b. Uncontrolled angina, congestive heart failure, or myocardial infarction within 6 months prior to enrollment
c. QTc interval prolongation based on Fridericia's formula (> 450 ms in males, > 470 ms in females)
12. Has received any investigational medication within 30 days or 5 halflives prior to Day 1, whichever is longer.
13. Has prior history of malignancies, other than follicular lymphoma, unless the patient has been free of the disease for = 3 years. Exceptions include localized prostate cancer that is being managed with active surveillance or a history of previously treated:
a. Localized non-melanoma skin cancer
b. Carcinoma in situ of the cervix
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