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RECRUITINGPhase 2INTERVENTIONAL

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

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)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: 1. diagnosed by tissue sample (biopsy-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. Who Should NOT Join This Trial: 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 weakened immune system 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). Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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).

Treatments Being Tested

DRUG

abexinostat

abexinostat tablet

Locations (20)

Cancer Hospital Chinese Academy of Medical Sciences
Beijing, China
China-Japan Friendship Hospital
Beijing, China
Peking University Third Hospital
Beijing, China
West China Hospital, Sichuan University
Chengdu, China
The First Affiliate Hospital of Dalian Medical University
Dalian, China
Fujian Medical University Union Hospital
Fuzhou, China
Fujian Provincial Cancer Hospital
Fuzhou, China
Cancer Center of Guangzhou Medical University
Guangzhou, China
Sun Yai-Sen Memorial Hospital, Sun Yai-Sen University
Guangzhou, China
Zhejiang Cancer Hospital
Hangzhou, China
The Affiliated Tumor Hospital of Harbin Medical University
Harbin, China
The First Hospital of Lanzhou University
Lanzhou, China
Linyi Cancer Hospital
Linyi, China
Nantong Tumor Hospital
Nantong, China
Shanghai Jiao Tong University School Medicine
Shanghai, China
Fudan University Shanghai Cancer Center
Shanghai, China
Second People's Hospital of Shenzhen
Shenzhen, China
The Forth Hospital of Hebei Medical University
Shijiazhuang, China
First Hospital of Shanxi Medical University
Taiyuan, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China