Lymphoma, Follicular
Conditions
Keywords
refractory, relapsed, lymph nodes
Brief summary
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 follicular lymphoma (FL)
Detailed description
This is an open-label, single-arm, two-stage, multi-center, phase 2 study in patients with relapsed/refractory follicular lymphoma (FL) who have received at least two prior standard therapy lines.
Interventions
DRUGAbexinostat
Abexinostat tablets
Sponsors
Xynomic Pharmaceuticals, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single Group Assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Life expectancy ≥ 3 months 2. Histologically confirmed grade 1, 2, or 3a follicular lymphoma (FL) 3. Have received at least two prior standard therapy lines including anti- cluster of differentiation antigen (anti-CD20) antibody and cytotoxic therapy for follicular lymphoma (FL) 4. Confirmed to be unresponsive to the last line of therapy (have stable disease or disease progression during treatment),or have disease progression following the last line of therapy 5. Have at least one radiologically measurable lymph node or extranodal lymphoid malignant lesion as assessed by computed tomography (CT) or magnetic resonance imaging (MRI); 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 7. Meet various hematological, liver function and renal function lab parameters
Exclusion criteria
1. Histologically confirmed grade 3b follicular lymphoma, or transformed diffuse large B-cell lymphoma (DLBCL) 2. Current or history of central nervous system (CNS) lymphoma; 3. Toxicity not yet recovered from previous anti-tumor therapies 4. Uncontrolled systemic infections or infections requiring intravenous antibiotics 5. Have previously treated by abexinostat or other histone deacetylase (HDAC) inhibitors; 6. Have received steroid hormone within 7 days, chemotherapy, targeted therapy within 28 days, radiotherapy within 14 days, anti-cancer antibody therapies within 28 days 7. Unable to swallow tablets, or presence of significant functional gastrointestinal disorders that may affect the oral administration and absorption of the study drug 8. Have received autologous stem cell transplant within 3 months before the first dose, or allogeneic stem cell transplant within 6 months before the first dose 9. Presence of active graft-versus-host disease 10. Have undergone a major surgery within 28 days 11. Evidence of possible human immunodeficiency virus (HIV) infection or hepatitis C virus (HCV) infection 12. Have cardiac impairment as defined per protocol 13. Have prior history of malignancies other than follicular lymphoma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical effect of abexinostat on objective response rate as assessed by an independent central imaging review | up to 56 days | Objective response rate (ORR), defined as the proportion of patients who have completed response (CR) or partial response (PR) 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
Outcome results
None listed