Study to Evaluate Efficacy and Safety of Oral Abexinostat in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)

• Status: Recruiting
• Trial end date: 2023-05-31
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xynomic Pharmaceuticals, Inc.
• Treatments: Abexinostat

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).