Diffuse Large B-cell Lymphoma (DLBCL)
Conditions
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)
Detailed description
An open-label, single-arm, multi-center phase 2 study to evaluate the efficacy and safety of oral histone deacetylase (HDAC)-inhibitor abexinostat, as monotherapy in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL)
Interventions
DRUGabexinostat
abexinostat tablet
Sponsors
Xynomic Pharmaceuticals, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A single arm treatment group
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical effect by evaluating the objective response rate (ORR) | up to 56 days | To evaluate the objective response rate (ORR) of abexinostat in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) as assessed by an independent central imaging review. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response | up to 56 days | Objective response rate (ORR) as assessed by the investigator |
| Progression-free survival | Up to 2 years | Progression-free survival (PFS), defined as the time from the initiation of treatment to disease progression or death as assessed by the independent Central Imaging Review and the Investigator. |
Countries
China
Contacts
Primary ContactBing Zhao, MD
Backup ContactSophia Paspal, PhD RAC
Outcome results
None listed