Study of Abexinostat in Patients With Relapsed or Refractory Follicular Lymphoma

NCT ID: NCT03600441

Last Updated: 2025-04-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 139 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-27
• Study Completion Date: 2029-12-31

Brief 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.

Detailed Description

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.

Conditions

Follicular Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Abexinostat

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).

Group Type: EXPERIMENTAL

Abexinostat

Intervention Type: DRUG

Abexinostat tosylate salt is formulated into an oral tablet formulation and is available in 20 mg strength.

Interventions

Abexinostat

Abexinostat tosylate salt is formulated into an oral tablet formulation and is available in 20 mg strength.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xynomic Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Connie W Batlevi, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Advocate Medical Group - Park Ridge, Luther Lane - Oncology

Park Ridge, Illinois, United States

Norton Cancer Institute - St. Matthews Campus

Louisville, Kentucky, United States

Clinical Research Alliance Inc

Lake Success, New York, United States

Manhattan Hematology Oncology Center

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Bone Marrow Transplant Hematology Oncology Associates

Pittsburgh, Pennsylvania, United States

Arlington Cancer Center

Arlington, Texas, United States

Central Texas Veterans Health Care System - NAVREF

Temple, Texas, United States

Vista Oncology Inc. PS

Olympia, Washington, United States

Centre Hospitalier de Perpignan

Perpignan, Pyrénées-Orientales, France

Hospital Universitario de Donostia

Donostia / San Sebastian, Guipúzcoa, Spain

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

Countries

United States; France; Spain

Related Links

https://www.fda.gov/Safety/Recalls/

FDA Safety Alerts

Other Identifiers

XYN-601

Identifier Type: -

Identifier Source: org_study_id