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

Xynomic Pharmaceuticals

Status and phase: Enrolling; Phase 2

Conditions: Diffuse Large B-cell Lymphoma (DLBCL)

Treatments: Drug: abexinostat

Study type: Interventional

Funder types: Industry

Identifiers

NCT03936153

XYN-606

Details and patient eligibility

About

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)

Full 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)

Enrollment: 170 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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170 participants in 1 patient group

Abexinostat 80 mg bis in die (BID)

Experimental group

Description:

Abexinostat 80 mg BID

Treatment:

Drug: abexinostat