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Clinical Trials in the USA / NCT03600441
Active, not recruiting Phase 2

Study of Abexinostat in Patients With Relapsed or Refractory Follicular Lymphoma

NCT03600441 · tracked via the Priya Life Science USA tracker
Sponsor
Xynomic Pharmaceuticals, Inc.
Phase
Phase 2
Started
2018-08-27
Last updated
2025-04-10

Condition(s) studied

Follicular Lymphoma

Investigational drug(s) / intervention(s)

Abexinostat

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)

Trial sites (15)

FacilityCityRegionStatus
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

Other trials for the same condition

Official registry record

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.

View NCT03600441 on ClinicalTrials.gov ↗ ← All trials in the USA