Relapsed or refractory Follicular Lymphoma MedDRA version: 20.1 Level: LLT Classification code 10080213 Term: In situ follicular lymphoma System Organ Class: 100000004864
Conditions
Sponsors
Xynomic Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 450 ms in males, > 470 ms in females) 12. Has received any investigational medication within 30 days or 5 half-lives 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the clinical efficacy of abexinostat in patients with relapsed/refractory follicular lymphoma based on the objective response rate (ORR).; Secondary Objective: The secondary objectives of this study include the following: - To evaluate the duration of response (DOR) in patients with elapsed/refractory follicular lymphoma treated with abexinostat. - To evaluate the progression free survival (PFS) in patients with relapsed/refractory follicular lymphoma treated with abexinostat. - To evaluate the clinical benefit rate (CBR) in patients with relapsed/refractory follicular lymphoma treated with abexinostat. - To evaluate the overall survival (OS) in patients with relapsed/refractory treated with abexinostat. - To characterize the safety and tolerability of abexinostat in patients with relapsed/refractory follicular lymphoma. - To investigate the pharmacokinetics and pharmacodynamics of abexinostat in patients with relapsed/refractory follicular lymphoma. ; Primary end point(s): Objective response defined as complete response (CR) or partial response (PR according to the Lugano 2014 criteria as determined by an Independent Review Committee (IRC). ;Timepoint(s) of evaluation of this end point: End of Cycle 2 or until patient no longer receive benefits or tolerates regimen | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Duration of response using the Lugano 2014 criteria Duration of response defined as the time from first documented evidence of CR or PR until disease progression or death from any cause among patients who achieve an objective response, according to the Lugano 2014 criteria as determined by an IRC. 2. Duration of response using the RECIL 2017 Defined as the time from first documented evidence of CR or PR from any cause among patients who achieve an objective response, according to the RECIL 2017 as determined by an IRC. Duration of response will be evaluated once more using the RECIL 2017 with the inclusion of MR (Minor Response) lasting = 6 months. 3. Progression free survival Defined as the time from the start of treatment until disease progression or death assessed using the Lugano 2014 criteria AND RECIL 2017 as determined by an IRC. 4. Clinical Benefit Defined as the best from CR, PR, or stable disease (SD) observed at the end of cycle 2 or later, according to the Lugano 2014 criteria AND RECIL 2017 as determined by an IRC. 5. Objective response Defined as CR or PR observed at the end of Cycle 2 or later according to the International Working Group consensus response evaluation criteria in lymphoma (RECIL 2017) as determined by an IRC. Objective response will be evaluated once more using the RECIL 2017 with the inclusion of minor response (MR) lasting = 6 months. 6. Overall survival Defined as the time from the start of treatment until death from any cause or last contact. 7. Safety Safety as measured by the incidence, severity, seriousness and relatedness of the treatment-emergent adverse events to study drug. 8. Change in the QTc interval Change from baseline in the QTc interval. ; | — |
Countries
Belarus, France, Greece, Hungary, Italy, Russian Federation, Spain, United States
Contacts
Public ContactProject Management
PPD
Outcome results
None listed