Follicular LymphomaPhase 2FORERUNNERNCT03600441
Study of Abexinostat in Patients With Relapsed or Refractory Follicular Lymphoma
A Phase 2 study testing Abexinostat in people with Follicular Lymphoma, run by Xynomic Pharmaceuticals, Inc. at 15 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Follicular Lymphoma
- What is being tested?
- Abexinostat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 15 sitesin 3 countries
- Study dates
- 27 Aug 2018to 31 Dec 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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.
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- Use highly effective forms of birth control (women of childbearing potential only), which include the following:
- 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.
Who cannot join
- 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
Trial locations and contacts
15 sites in 3 countries.
15 sites in 3 countries
United States9 sites
Arlington Cancer Center
Arlington, Texas, 76012
Clinical Research Alliance Inc
Lake Success, New York, 11042
Norton Cancer Institute - St. Matthews Campus
Louisville, Kentucky, 40207
Manhattan Hematology Oncology Center
New York, New York, 10016
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Vista Oncology Inc. PS
Olympia, Washington, 98506
Advocate Medical Group - Park Ridge, Luther Lane - Oncology
Park Ridge, Illinois, 60068
Bone Marrow Transplant Hematology Oncology Associates
Pittsburgh, Pennsylvania, 15224-2156
Central Texas Veterans Health Care System - NAVREF
Temple, Texas, 76504
Spain5 sites
Hospital Universitario Vall d'Hebrón
Barcelona, 08035
Hospital del Mar
Barcelona, 28229
C.H. Regional Reina Sofia
Córdoba, 14004
Hospital Universitario de Donostia
Donostia / San Sebastian, Guipúzcoa, 20014
Hospital Universitario Infanta Leonor
Madrid, 28031
France1 site
Centre Hospitalier de Perpignan
Perpignan, Pyrénées-Orientales, 66046
About this study
Official title: Open-label, Single-Arm, Phase 2 Study of Oral HDAC-inhibitor Abexinostat in Patients With Relapsed or Refractory Follicular Lymphoma (FORERUNNER)
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.
Read the 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
- Being tested
- Abexinostat
- Keywords
- cancer
- Medical subject headings
- Lymphoma, Follicular, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbexinostatDrug
Abexinostat tosylate salt is formulated into an oral tablet formulation and is available in 20 mg strength.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Abexinostat |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Time frame up to 100 months
Secondary outcomes (9)
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.
Measured: At the end of cycle 2 (each cycle is 28 days) and through study completion, assessed up to 100 months.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start27 Aug 2018
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Follicular LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- open label
- Masking
- None (open label)
- Enrolment
- 139 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xynomic Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Connie W Batlevi, MD,PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03600441
- Sponsor's protocol ID
- XYN-601
- Acronym
- FORERUNNER
- Status last verified
- Apr 2025
- First submitted
- 23 Jun 2018
- Last updated
- 10 Apr 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Single-Arm, Phase 2 Study of Oral HDAC-inhibitor Abexinostat in Patients With Relapsed or Refractory Follicular Lymphoma (FORERUNNER)
- ClinicalTrials.gov ID
- NCT03600441
- Acronym / sponsor ID
- FORERUNNER / XYN-601
- Conditions
- Follicular Lymphoma
- Keywords
- cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 139 participants (estimated)
- Lead sponsor
- Xynomic Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Aug 2018 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 26 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- open label
| Arm | Type | Receives |
|---|---|---|
| Abexinostat | Experimental | Drug: AbexinostatAbexinostat 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AbexinostatAbexinostat tosylate salt is formulated into an oral tablet formulation and is available in 20 mg strength. | Drug | Abexinostat |
Primary outcome
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).
9 secondary outcomes
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.
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
Clinical Benefit
Time frame: At the end of cycle 2 (each cycle is 28 days) and through study completion, assessed up to 100 months.
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
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
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- FDA Safety AlertsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Connie W Batlevi, MD,PhD principal investigator
Memorial Sloan Kettering Cancer Center
15 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Abexinostat in people with Follicular Lymphoma, run by Xynomic Pharmaceuticals, Inc. at 15 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Spain, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical effect of abexinostat (time frame: Time frame up to 100 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.