Active, not recruiting
Phase 2
Study of Abexinostat in Patients With Relapsed or Refractory Follicular Lymphoma
Condition(s) studied
Follicular Lymphoma
Investigational drug(s) / intervention(s)
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
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 |
|
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