Study of Abexinostat in Patients With Relapsed or Refractory Follicular Lymphoma

Running, not enrolling · Phase 2

Conditions studied: Follicular Lymphoma

In brief

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.

Key facts

Study ID

NCT03600441

Run by

Xynomic Pharmaceuticals, Inc.

People needed

139

Starts

2018-08-27

Expected to finish

2029-12-31

Last updated by the study team

2025-04-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Advocate Medical Group - Park Ridge, Luther Lane - Oncology — Park Ridge, Illinois, United States
• Norton Cancer Institute - St. Matthews Campus — Louisville, Kentucky, United States
• 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
• Hospital Universitario de Donostia — Donostia / San Sebastian, Guipúzcoa, Spain
• 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

Full record on ClinicalTrials.gov

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