A Phase 2 interventional study of Abexinostat in Follicular Lymphoma, sponsored by Xynomic Pharmaceuticals, Inc.. Active, not recruiting at 15 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-10.
Sponsored by Xynomic Pharmaceuticals, Inc. · Phase 2, Interventional, and Treatment
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.
5,579 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's planned enrollment of 139 is above the median of 40 across 4,509 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Xynomic Pharmaceuticals, Inc. is the lead sponsor of 6 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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)
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.
Exclusion Criteria:
Abexinostat tablets will be administered orally at 80 mg (4 × 20 mg tablets) BID (twice a day) 4 hours apart for 7 days in a "one week on, one week off" schedule (on Days 1 to 7 and Days 15 to 21 of each 28-day cycle).
Drug: Abexinostat
Abexinostat tosylate salt is formulated into an oral tablet formulation and is available in 20 mg strength.
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.
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
Plan to share: No
This study is active, not recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Xynomic Pharmaceuticals, Inc.