Study to Evaluate Efficacy and Safety of Oral Abexinostat in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: abexinostat.
- Who it may be relevant to
- Registry conditions: Diffuse Large B-cell Lymphoma (DLBCL). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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)
Overview
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
- Drug abexinostat
abexinostat tablet
Primary outcome measures
- Clinical effect by evaluating the objective response rate (ORR) [Time frame: up to 56 days]
Secondary outcome measures (2)
- Objective Response [Time frame: up to 56 days]
- Progression-free survival [Time frame: Up to 2 years]
Eligibility criteria
Inclusion criteria
- Histologically confirmed diffuse large B-cell lymphoma (DLBCL);
- 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;
- Confirmed to be unresponsive to the last line of therapy, or have disease progression following the last line of therapy;
- Have at least one radiologically measurable lymph node or extranodal lymphoid malignant lesion;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2;
- Meet various hematological, liver and renal function lab parameters.
Exclusion criteria
- 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;
- Toxicity not yet recovered from previous anti-tumor therapies;
- Uncontrolled systemic infections or infections requiring intravenous antibiotics;
- Have received steroid hormone, chemotherapy, targeted therapy, radiotherapy, antibody-based therapies, within a specified amount of time per protocol;
- Unable to swallow tablets, or presence of significant functional gastrointestinal disorders that may affect the intake, transport or absorption of the study drug;
- Have received autologous stem cell transplant,or allogeneic stem cell transplant within a certain amount of time as specified in protocol;
- Presence of active graft-versus-host reaction;
- Have undergone a major surgery within the last month;
- Evidence of possible human immunodeficiency virus (HIV) infection or hepatitis C virus (HCV) infection;
- Have any cardiac impairment as defined per protocol;
- Have prior history of malignancies other than diffuse large B-cell lymphoma (DLBCL).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 23 centers
- Cancer Hospital Chinese Academy of Medical Sciences — Beijing
- China-Japan Friendship Hospital — Beijing
- Peking University Third Hospital — Beijing
- West China Hospital, Sichuan University — Chengdu
- The First Affiliate Hospital of Dalian Medical University — Dalian
- Fujian Medical University Union Hospital — Fuzhou
- Fujian Provincial Cancer Hospital — Fuzhou
- Cancer Center of Guangzhou Medical University — Guangzhou
- … and 15 more centers
Identifiers
NCT: NCT03936153 · XYN-606