Study to Evaluate Efficacy and Safety of Oral Abexinostat in Patients With Relapsed or Ref
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)
| Condition(s) | Diffuse Large B-cell Lymphoma (DLBCL) |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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) |
| Who can participate | 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 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Xynomic Pharmaceuticals, Inc. |
| Locations | Beijing, China; Beijing, China; Beijing, China; Chengdu, China; Dalian, China; Fuzhou, China (+17 more sites) |
| Start date | 2020-01-20 |
| NCT ID | NCT03936153 |
| Official listing | https://clinicaltrials.gov/study/NCT03936153 |