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NCT Number: NCT03600441

Study of Abexinostat in Patients With Relapsed or Refractory Follicular Lymphoma

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centre Hospitalier de Perpignan, Perpignan, Pyrénées-Orientales, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Abexinostat

Drug

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

Primary outcomes

  1. Clinical effect of abexinostat

    Time frame: 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).

Secondary outcomes

  1. Duration of response

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

    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.

  2. Progression free survival

    Time frame: 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

    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.

  3. Clinical Benefit

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

    Defined as the best from CR, PR, or stable disease (SD) according to the Lugano 2014 criteria as determined by an IRC.

  4. Overall survival

    Time frame: 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

    Defined as the time from the start of treatment until death from any cause or last contact.

  5. Duration of response

    Time frame: 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

    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.

  6. Incidence of adverse events

    Time frame: 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

    Safety as measured by the incidence of adverse events

  7. Incidence of serious adverse events

    Time frame: 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

    Safety as measured by the serious of adverse events (SAE)

  8. Incidence of non-serious adverse events

    Time frame: 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

    Safety as measured by the non-serious of adverse events

  9. Change in the interval corrected for heart rate (QTc) interval

    Time frame: 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 from baseline in the QTc interval.

Sponsors and collaborators

Lead sponsor

Xynomic Pharmaceuticals, Inc.

Industry

Registry information

Official study title

Open-label, Single-Arm, Phase 2 Study of Oral HDAC-inhibitor Abexinostat in Patients With Relapsed or Refractory Follicular Lymphoma (FORERUNNER)

Acronym: FORERUNNER

Important dates

Study start
2018
Primary completion
2027
Study completion
2029
First posted
Jul 26, 2018
Registry last updated
Apr 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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