Home
Clinical Trials
Study to Evaluate Efficacy an...

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

Last Updated: 2025-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-20

Study Completion Date

2027-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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)

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Multi-Center Phase 2 Study to Evaluate Efficacy and Safety of Oral Abexinostat as Monotherapy in Patients With Relapsed or Refractory Follicular Lymphoma

NCT03934567

Lymphoma, Follicular

ACTIVE_NOT_RECRUITING PHASE2

Study of Abexinostat in Patients With Relapsed or Refractory Follicular Lymphoma

NCT03600441

Follicular Lymphoma

ACTIVE_NOT_RECRUITING PHASE2

Study of Tisagenlecleucel in Combination With Pembrolizumab in r/r Diffuse Large B-cell Lymphoma Patients

NCT03630159

Diffuse Large B-cell Lymphoma

COMPLETED PHASE1

R-MINE+X in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma

NCT05784987

Diffuse Large B-cell Lymphoma

UNKNOWN NA

PXD101 in Treating Patients With Relapsed or Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma

NCT00303953

Recurrent Adult Burkitt Lymphoma Recurrent Adult Diffuse Large Cell Lymphoma

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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)

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diffuse Large B-cell Lymphoma (DLBCL)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

Intervention Model

SINGLE_GROUP

A single arm treatment group

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Abexinostat 80 mg bis in die (BID)

Abexinostat 80 mg BID

Group Type EXPERIMENTAL

abexinostat

Intervention Type DRUG

abexinostat tablet

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

abexinostat

abexinostat tablet

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers