Abexinostat: Abexinostat tosylate salt is formulated into an oral tablet formulation and is available in 20 mg strength.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Is able to understand and voluntarily sign an informed consent document before any study related assessments/procedures are conducted.
* Has histologically confirmed Grade 1, 2, or 3a follicular lymphoma.
* 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 radiologically measuring ≥ 3 cm in its longest diameter).
* 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)
* 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.
* 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.
* 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.
* 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.
* 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.
Exclusion Criteria:
* Has diagnosis of Grade 3b follicular lymphoma, or transformation to diffuse large B-cell lymphoma
* Has a history of central nervous system lymphoma (either primary or secondary).
* Has had prior treatment with abexinostat.
* Has had allogeneic stem cell transplant within the last 6 months, or autologous stem cell transplant within the last 3 months before enrollment
* Has any types of cardiac impairment at the time of enrollment
* Has received any investigational medication within 30 days or 5 half-lives prior to Day 1, whichever is longer
* Has prior history of malignancies, other than follicular lymphoma, unless the patient has been free of the disease for ≥ 3 years
Primary outcome measure(s)
Clinical effect of abexinostat — Time frame up to 100 months Complete response (CR) or partial response (PR) according to the Lugano 2014 criteria as determined by an Independent Review Committee (IRC).
Trial sites (15)
Facility
City
Region
Status
Advocate Medical Group - Park Ridge, Luther Lane - Oncology
Park Ridge
Illinois
Norton Cancer Institute - St. Matthews Campus
Louisville
Kentucky
Clinical Research Alliance Inc
Lake Success
New York
Manhattan Hematology Oncology Center
New York
New York
Memorial Sloan Kettering Cancer Center
New York
New York
Bone Marrow Transplant Hematology Oncology Associates
Pittsburgh
Pennsylvania
Arlington Cancer Center
Arlington
Texas
Central Texas Veterans Health Care System - NAVREF
Temple
Texas
Vista Oncology Inc. PS
Olympia
Washington
Centre Hospitalier de Perpignan
Perpignan
Pyrénées-Orientales
Hospital Universitario de Donostia
Donostia / San Sebastian
Guipúzcoa
Hospital Universitario Vall d'Hebrón
Barcelona
Spain
Hospital del Mar
Barcelona
Spain
C.H. Regional Reina Sofia
Córdoba
Spain
Hospital Universitario Infanta Leonor
Madrid
Spain
More Xynomic Pharmaceuticals, Inc. trials in the USA
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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