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

Launched by XYNOMIC PHARMACEUTICALS, INC. · May 1, 2019

Keywords

ClinConnect Summary

This clinical trial is looking at a new oral medication called abexinostat to see how well it works and how safe it is for people with a type of blood cancer called diffuse large B-cell lymphoma (DLBCL) that has not responded to previous treatments. The study is currently recruiting participants who are between the ages of 65 and 74. To be eligible, patients must have a confirmed diagnosis of DLBCL, have already tried two different standard treatments, and show that their cancer has not improved or has worsened after their last treatment.

Participants in this trial will take abexinostat by mouth and will be closely monitored to see how their cancer responds and if they experience any side effects. It's important to note that certain individuals are not eligible to join the study, including those with other specific types of lymphoma or certain health conditions. This trial offers a potential new treatment option for patients whose cancer has not responded to existing therapies, and it aims to contribute valuable information to help improve future care for DLBCL.

Gender

ALL

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).