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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.
Patients will be evaluated for objective response, Duration of Response (DOR), Progression Free Survival (PFS), Clinical Benefit Rate (CBR), Overall survival (OS), safety and tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and changes in health related quality of life. Patients may receive treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent. An independent data safety monitoring committee (iDMC) will evaluate the data pertaining to the futility and decide whether the study should stop or continue to the second stage. If the study continues to the second stage, a total of 139 patients will be studied.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abexinostat | Experimental | Abexinostat tablets will be administered orally at 80 mg (4 × 20 mg tablets) BID (twice a day) 4 hours apart for 7 days in a "one week on, one week off" schedule (on Days 1 to 7 and Days 15 to 21 of each 28-day cycle). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abexinostat | Drug | Abexinostat tosylate salt is formulated into an oral tablet formulation and is available in 20 mg strength. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical effect of abexinostat | Complete response (CR) or partial response (PR) according to the Lugano 2014 criteria as determined by an Independent Review Committee (IRC). | Time frame up to 100 months |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of response | Duration of response defined as the time from first documented evidence of CR or PR until disease progression or death from any cause among patients who achieve an objective response, according to the Lugano 2014 criteria as determined by an IRC. | At the end of cycle 2 (each cycle is 28 days) and through study completion, assessed up to 100 months. |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Connie W Batlevi, MD,PhD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advocate Medical Group - Park Ridge, Luther Lane - Oncology | Park Ridge | Illinois | 60068 | United States | ||
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| Label | URL |
|---|---|
| FDA Safety Alerts | View source |
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open label
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| Progression free survival | Defined as the time from the start of treatment until disease progression or death assessed using the Lugano 2014 criteria as determined by an IRC. | From date of randomization until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months |
| Clinical Benefit | Defined as the best from CR, PR, or stable disease (SD) according to the Lugano 2014 criteria as determined by an IRC. | At the end of cycle 2 (each cycle is 28 days) and through study completion, assessed up to 100 months. |
| Overall survival | Defined as the time from the start of treatment until death from any cause or last contact. | From date of randomization until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months |
| Duration of response | Defined as the time from first documented evidence of CR or PR from any cause among patients who achieve an objective response, according to the RECIL 2017 as determined by an IRC. Duration of response will be evaluated once more using the RECIL 2017 with the inclusion of Minor Response (MR) lasting ≥ 6 months. | At the end of cycle 2 (each cycle is 28 days) or from date of randomization until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months |
| Incidence of adverse events | Safety as measured by the incidence of adverse events | At the end of cycle 2 (each cycle is 28 days) or from date of randomization until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months |
| Incidence of serious adverse events | Safety as measured by the serious of adverse events (SAE) | At the end of cycle 2 (each cycle is 28 days) or from date of randomization until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months |
| Incidence of non-serious adverse events | Safety as measured by the non-serious of adverse events | At the end of cycle 2 (each cycle is 28 days) or from date of randomization until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months |
| Change in the interval corrected for heart rate (QTc) interval | Change from baseline in the QTc interval. | At the end of cycle 2 (each cycle is 28 days) or from date of randomization until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months |
| Norton Cancer Institute - St. Matthews Campus |
| Louisville |
| Kentucky |
| 40207 |
| United States |
| Clinical Research Alliance Inc | Lake Success | New York | 11042 | United States |
| Manhattan Hematology Oncology Center | New York | New York | 10016 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Bone Marrow Transplant Hematology Oncology Associates | Pittsburgh | Pennsylvania | 15224-2156 | United States |
| Arlington Cancer Center | Arlington | Texas | 76012 | United States |
| Central Texas Veterans Health Care System - NAVREF | Temple | Texas | 76504 | United States |
| Vista Oncology Inc. PS | Olympia | Washington | 98506 | United States |
| Centre Hospitalier de Perpignan | Perpignan | Pyrénées-Orientales | 66046 | France |
| Hospital Universitario de Donostia | Donostia / San Sebastian | Guipúzcoa | 20014 | Spain |
| Hospital Universitario Vall d'Hebrón | Barcelona | 08035 | Spain |
| Hospital del Mar | Barcelona | 28229 | Spain |
| C.H. Regional Reina Sofia | Córdoba | 14004 | Spain |
| Hospital Universitario Infanta Leonor | Madrid | 28031 | Spain |
| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C512352 | abexinostat |
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