Study on Abexinostat for Patients with Relapsed or Hard-to-Treat Follicular Lymphoma
Sponsor: Xynomic Pharmaceuticals, Inc.
ClinicalTrials ID:NCT03600441
This clinical trial is testing the drug Abexinostat in patients with follicular lymphoma that has returned or not responded to at least three previous treatments. Participants will take the medication in a specific schedule to see if it helps control the cancer.
Patient Parameters
| Parameter | Options |
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Program Overview
The study is designed for patients with follicular lymphoma that has either come back after treatment or hasn't responded to previous therapies. Participants will take Abexinostat tablets twice a day for one week, followed by a week off, in a repeating cycle. The study aims to evaluate how well the drug works in controlling the cancer, how long the benefits last, and its safety. Researchers will also look at how the drug affects patients' quality of life. The study will continue until the cancer progresses, side effects become too severe, or the patient decides to stop. An independent committee will review the study's progress to decide if it should continue.
Description
This study is testing Abexinostat, a medication for patients with follicular lymphoma that has returned or not responded to previous treatments. Participants will take the drug in cycles: one week on, one week off. The study will measure how well the drug works in shrinking tumors, how long patients benefit from the treatment, and overall survival rates. It will also assess the safety and side effects of the drug, as well as its impact on patients' quality of life. Patients can continue the treatment until their cancer worsens, they experience unacceptable side effects, or they choose to withdraw from the study. An independent committee will monitor the study's progress and decide if it should continue to the next phase, which will include a total of 139 patients.
Eligibility Criteria
Inclusion Criteria
- Able to understand and sign a consent form before any study procedures.
- Diagnosed with Grade 1, 2, or 3a follicular lymphoma.
- The lymphoma has returned after treatment or hasn't responded to the last treatment and needs further treatment.
- Female participants must be postmenopausal, surgically sterile, or use effective birth control.
- Male participants must agree not to donate sperm during the study and for 90 days after the last dose.
- Female participants must agree not to breastfeed during the study and for 90 days after the last dose.
- Male participants and their female partners must use effective birth control during the study and for 90 days after the last dose.
Exclusion Criteria
- Diagnosed with Grade 3b follicular lymphoma or transformed to diffuse large B-cell lymphoma.
- History of lymphoma affecting the brain or spinal cord.
- Previous treatment with Abexinostat.
- Recent stem cell transplant (within 6 months for allogeneic or 3 months for autologous).
- Any heart problems at the time of joining the study.
- Received any experimental medication within 30 days before starting the study.
- History of other cancers unless free of disease for 3 years or more.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Advocate Medical Group - Park Ridge, Luther Lane - Oncology | 60068 | Park Ridge | Illinois |
| Norton Cancer Institute - St. Matthews Campus | 40207 | Louisville | Kentucky |
| Clinical Research Alliance Inc | 11042 | Lake Success | New York |
| Manhattan Hematology Oncology Center | 10016 | New York | New York |
| Memorial Sloan Kettering Cancer Center | 10065 | New York | New York |
| Bone Marrow Transplant Hematology Oncology Associates | 15224-2156 | Pittsburgh | Pennsylvania |
| Arlington Cancer Center | 76012 | Arlington | Texas |
| Central Texas Veterans Health Care System - NAVREF | 76504 | Temple | Texas |
| Vista Oncology Inc. PS | 98506 | Olympia | Washington |
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