Study of Abexinostat in Patients With Relapsed or Refractory Follicular Lymphoma

NCT03600441 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: XYN-601
• Study Type: interventional
• Target: 139
• Locations: 3 countries
• Sites: 15

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.

Conditions

Follicular Lymphoma

Keywords

cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (9)

• Duration of response

  At the end of cycle 2 (each cycle is 28 days) and through study completion, assessed up to 100 months.

• Progression free survival

  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

  At the end of cycle 2 (each cycle is 28 days) and through study completion, assessed up to 100 months.

• Overall survival

  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

  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

Study Arms (1)

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).

Drug: Abexinostat

Interventions

Abexinostat DRUG

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

Abexinostat

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Xynomic Pharmaceuticals, Inc.: lead

Study Sites (15)

Advocate Medical Group - Park Ridge, Luther Lane - Oncology

Park Ridge, Illinois, 60068, United States

Location

Norton Cancer Institute - St. Matthews Campus

Louisville, Kentucky, 40207, United States

Location

Clinical Research Alliance Inc

Lake Success, New York, 11042, United States

Location

Manhattan Hematology Oncology Center

New York, New York, 10016, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Bone Marrow Transplant Hematology Oncology Associates

Pittsburgh, Pennsylvania, 15224-2156, United States

Location

Arlington Cancer Center

Arlington, Texas, 76012, United States

Location

Central Texas Veterans Health Care System - NAVREF

Temple, Texas, 76504, United States

Location

Vista Oncology Inc. PS

Olympia, Washington, 98506, United States

Location

Centre Hospitalier de Perpignan

Perpignan, Pyrénées-Orientales, 66046, France

Location

Hospital Universitario de Donostia

Donostia / San Sebastian, Guipúzcoa, 20014, Spain

Location

Hospital Universitario Vall d'Hebrón

Barcelona, 08035, Spain

Location

Hospital del Mar

Barcelona, 28229, Spain

Location

C.H. Regional Reina Sofia

Córdoba, 14004, Spain

Location

Hospital Universitario Infanta Leonor

Madrid, 28031, Spain

Location

Related Links

• FDA Safety Alerts

MeSH Terms

Conditions

Lymphoma, Follicular; Neoplasms

Interventions

abexinostat

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Connie W Batlevi, MD,PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: open label

Study Record Dates

• First Submitted: June 23, 2018
• First Posted: July 26, 2018
• Study Start: August 27, 2018
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2029
• Last Updated: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (9); ES (5); FR (1)