Study of Abexinostat in Patients With Relapsed or Refractory Follicular Lymphoma

• Status: Active, not recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xynomic Pharmaceuticals, Inc.
• Treatments: Abexinostat

Criteria

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