This study in patients with relapsed/refractory follicular lymphoma who have undergone at least 3 lines of therapy. Patients will receive abexinostat 80 mg (4 × 20 mg tablets) twice a day (BID) in a "one week on, one week off" schedule.
Patients will be evaluated for objective response, Duration of Response (DOR), Progression Free Survival (PFS), Clinical Benefit Rate (CBR), Overall survival (OS), safety and tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and changes in health related quality of life. Patients may receive treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent. An independent data safety monitoring committee (iDMC) will evaluate the data pertaining to the futility and decide whether the study should stop or continue to the second stage. If the study continues to the second stage, a total of 139 patients will be studied.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
139
Abexinostat tosylate salt is formulated into an oral tablet formulation and is available in 20 mg strength.
Advocate Medical Group - Park Ridge, Luther Lane - Oncology
Park Ridge, Illinois, United States
Norton Cancer Institute - St. Matthews Campus
Louisville, Kentucky, United States
Clinical effect of abexinostat
Complete response (CR) or partial response (PR) according to the Lugano 2014 criteria as determined by an Independent Review Committee (IRC).
Time frame: Time frame up to 100 months
Duration of response
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.
Time frame: At the end of cycle 2 (each cycle is 28 days) and through study completion, assessed up to 100 months.
Progression free survival
Defined as the time from the start of treatment until disease progression or death assessed using the Lugano 2014 criteria as determined by an IRC.
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months
Clinical Benefit
Defined as the best from CR, PR, or stable disease (SD) according to the Lugano 2014 criteria as determined by an IRC.
Time frame: At the end of cycle 2 (each cycle is 28 days) and through study completion, assessed up to 100 months.
Overall survival
Defined as the time from the start of treatment until death from any cause or last contact.
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months
Duration of response
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 Minor Response (MR) lasting ≥ 6 months.
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Clinical Research Alliance Inc
Lake Success, New York, United States
Manhattan Hematology Oncology Center
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Bone Marrow Transplant Hematology Oncology Associates
Pittsburgh, Pennsylvania, United States
Arlington Cancer Center
Arlington, Texas, United States
Central Texas Veterans Health Care System - NAVREF
Temple, Texas, United States
Vista Oncology Inc. PS
Olympia, Washington, United States
Centre Hospitalier de Perpignan
Perpignan, Pyrénées-Orientales, France
...and 5 more locations
Time frame: At the end of cycle 2 (each cycle is 28 days) or from date of randomization until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months
Incidence of adverse events
Safety as measured by the incidence of adverse events
Time frame: At the end of cycle 2 (each cycle is 28 days) or from date of randomization until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months
Incidence of serious adverse events
Safety as measured by the serious of adverse events (SAE)
Time frame: At the end of cycle 2 (each cycle is 28 days) or from date of randomization until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months
Incidence of non-serious adverse events
Safety as measured by the non-serious of adverse events
Time frame: At the end of cycle 2 (each cycle is 28 days) or from date of randomization until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months
Change in the interval corrected for heart rate (QTc) interval
Change from baseline in the QTc interval.
Time frame: At the end of cycle 2 (each cycle is 28 days) or from date of randomization until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months