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FORERUNNER: Open-label, single-arm, phase 2 study of oral HDAC-inhibitor abexinostat in patients with relapsed or refractory follicular lymphoma

Description

This study in patients with relapsed/refractory follicular lymphoma who have undergone at least three 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.

Status

Accepting new patients

Primary Study Objective(s)

To evaluate the clinical efficacy of abexinostat in patients with relapsed/refractory follicular lymphoma based on the objective response rate (ORR).

Core eligibility

Note: This is only a partial list of eligibility criteria.

Including patients who:

  • Are able to understand and voluntarily sign an informed consent document before any study-related assessments/procedures are conducted
  • Have a histologically confirmed grade 1, 2, or 3a follicular lymphoma
  • Have follicular lymphoma that has relapsed after (progressed after six months from the start of therapy) or is refractory to the last line of therapy (no response or progression within six months from the start of therapy) and needs treatment (must have at least one lymph node or extranodal lymphoid malignancy radiologically measuring ≥ 3 cm in its longest diameter)
  • Are female and of non-childbearing potential, defined as follows:  
    • Postmenopausal (i.e. ≥ 1 year without any menses) prior to screening, or
    • Documented surgically sterile (≥ 1 month prior to screening)
  • Are male and 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 consistent and correct use of established oral contraception 
    • An established intrauterine device or intrauterine system 
    • Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository
  • Are female and agree not to breastfeed starting from the time of screening, throughout the study, and until after 90 days following the last dose
  • Are male and their female spouse/partners who are of childbearing potential use highly effective contraception methods consisting of two forms of birth control (at least one of which must be a barrier method) from the time of screening, throughout the study, and until after 90 days following treatment
  • Are male and agree not to donate sperm starting from the time of screening, throughout the study, and until after 90 days following the last dose

Excluding patients who have:

  • A diagnosis of grade 3b follicular lymphoma, or transformation to diffuse large B-cell lymphoma
  • A history of central nervous system lymphoma (either primary or secondary)
  • Had prior treatment with abexinostat
  • Had an allogeneic stem cell transplant within the last six months, or an autologous stem cell transplant within the last three months before enrollment
  • Had any type of cardiac impairment at the time of enrollment
  • Received any investigational medication within 30 days or five half-lives prior to day one, whichever is longer
  • A prior history of malignancies, other than follicular lymphoma, unless the patient has been free of the disease for ≥ 3 years

Learn more about non-Hodgkin lymphoma

     

Accepting new patients

 

Learn more at

clinicaltrials.gov

 

Principal Investigator(s)