Clinical trial · Interventional
Study of Abexinostat in Patients With Relapsed or Refractory Follicular Lymphoma
Open-label, Single-Arm, Phase 2 Study of Oral HDAC-inhibitor Abexinostat in Patients With Relapsed or Refractory Follicular Lymphoma (FORERUNNER)
NCT03600441CI-TRIAL-00088427FORERUNNERactive not recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Follicular Lymphoma | Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abexinostat | Drug | Abexinostat | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Abexinostat
- description
- 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).
- interventionNames
- Drug: Abexinostat
Primary outcomes (1)
- measure
- Clinical effect of abexinostat
- timeFrame
- Time frame up to 100 months
- description
- Complete response (CR) or partial response (PR) according to the Lugano 2014 criteria as determined by an Independent Review Committee (IRC).
Secondary outcomes (9)
- measure
- Duration of response
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.