NCT03936153 Study to Evaluate Efficacy and Safety of Oral Abexinostat in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)
| NCT ID | NCT03936153 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Xynomic Pharmaceuticals, Inc. |
| Condition | Diffuse Large B-cell Lymphoma (DLBCL) |
| Study Type | INTERVENTIONAL |
| Enrollment | 170 participants |
| Start Date | 2020-01-20 |
| Primary Completion | 2026-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 170 participants in total. It began in 2020-01-20 with a primary completion date of 2026-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
An open-label, single-arm, multi-center phase 2 study to evaluate the efficacy and safety of abexinostat, as monotherapy in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL)
Eligibility Criteria
Inclusion Criteria: 1. Histologically confirmed diffuse large B-cell lymphoma (DLBCL); 2. Have received only two prior standard therapy lines for diffuse large B-cell lymphoma (DLBCL) including anti- cluster of differentiation antigen (anti-CD20) antibody and cytotoxic therapy; 3. Confirmed to be unresponsive to the last line of therapy, or have disease progression following the last line of therapy; 4. Have at least one radiologically measurable lymph node or extranodal lymphoid malignant lesion; 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2; 6. Meet various hematological, liver and renal function lab parameters. Exclusion Criteria: 1. Have primary central nervous system (CNS) lymphoma or secondary central nervous system (CNS) infiltration, transformed lymphoma, unclassified B-cell lymphoma with features intermediate between DLBCL and classical Hodgkin's lymphoma (HL), primary effusion lymphoma, plasma lymphoma; 2. Toxicity not yet recovered from previous anti-tumor therapies; 3. Uncontrolled systemic infections or infections requiring intravenous antibiotics; 4. Have received steroid hormone, chemotherapy, targeted therapy, radiotherapy, antibody-based therapies, within a specified amount of time per protocol; 5. Unable to swallow tablets, or presence of significant functional gastrointestinal disorders that may affect the intake, transport or absorption of the study drug; 6. Have received autologous stem cell transplant,or allogeneic stem cell transplant within a certain amount of time as specified in protocol; 7. Presence of active graft-versus-host reaction; 8. Have undergone a major surgery within the last month; 9. Evidence of possible human immunodeficiency virus (HIV) infection or hepatitis C virus (HCV) infection; 10. Have any cardiac impairment as defined per protocol; 11. Have prior history of malignancies other than diffuse large B-cell lymphoma (DLBCL).
Contact & Investigator
Yuankai SHI, Prof
PRINCIPAL INVESTIGATOR
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Frequently Asked Questions
Who can join the NCT03936153 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Diffuse Large B-cell Lymphoma (DLBCL). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03936153 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT03936153 currently recruiting?
Yes, NCT03936153 is actively recruiting participants. Contact the research team at bing.zhao@xynomicpharma.com for enrollment information.
Where is the NCT03936153 trial being conducted?
This trial is being conducted at Beijing, China, Beijing, China, Beijing, China, Chengdu, China and 11 additional locations.
Who is sponsoring the NCT03936153 clinical trial?
NCT03936153 is sponsored by Xynomic Pharmaceuticals, Inc.. The principal investigator is Yuankai SHI, Prof at Cancer Institute and Hospital, Chinese Academy of Medical Sciences. The trial plans to enroll 170 participants.