Evaluating oral abexinostat for patients with relapsed or refractory DLBCL

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, single-arm, multi-center phase 2 study aimed at assessing the efficacy and safety of abexinostat, an oral histone deacetylase (HDAC) inhibitor, in patients diagnosed with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Participants will receive abexinostat as a monotherapy after having undergone two prior standard therapy lines, including anti-CD20 antibody and cytotoxic therapy. The study will measure the drug's effectiveness and safety profile in this specific patient population.

Why it matters

Who can join: the full rules

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).

Where it's running

• Cancer Hospital Chinese Academy of Medical Sciences
  Beijing, China Recruiting
• China-Japan Friendship Hospital
  Beijing, China Recruiting
• Peking University Third Hospital
  Beijing, China Recruiting
• West China Hospital, Sichuan University
  Chengdu, China Recruiting
• The First Affiliate Hospital of Dalian Medical University
  Dalian, China Recruiting
• Fujian Medical University Union Hospital
  Fuzhou, China Recruiting

Study contacts

• Principal investigator: Yuankai SHI, Prof — Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Study coordinator: Bing Zhao, MD
• Email: bing.zhao@xynomicpharma.com
• Phone: (01186)13716386801

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• ctDNA testing in newly diagnosed DLBCL or HGBL to predict treatment outcomes

  This study checks if measuring circulating tumor DNA in blood after first-line therapy can predict whether the disease will stay away or come back in people with DLBCL or HGBL.

  Recruiting at 2 sites Peking University People's Hospital · Beijing, Beijing Municipality and 1 other locations · NCT07878351

• Proton Therapy for Mediastinal Lymphoma in Denmark

  This study tests whether using proton therapy for mediastinal lymphoma can lower late-toxicity risk compared with photon therapy in adults.

  Recruiting Copenhagen University Hospital, Rigshospitalet · Copenhagen, Select A State · NCT07817641

• Memory-Enhanced CAR-T Therapy for Relapsed/Refractory Large B-Cell Lymphoma

  This trial tests memory-enhanced 7×19-THEMIS CAR-T cells in adults with relapsed or refractory large B-cell lymphoma to see how safe they are and whether tumors shrink or disappear.

  Recruiting Phase 1/2 Second Affiliated Hospital, Zhejiang University, School of Medicine · Hangzhou, Zhejiang · NCT07788118

• UB-VV400 with rapamycin in relapsed/refractory B-cell lymphomas

  A phase 1/2 trial tests UB-VV400 plus rapamycin in adults with relapsed or refractory B-cell lymphomas to see if it is safe and shows anti-tumor activity.

  Recruiting at 2 sites Phase 1/2 Umoja Biopharma · Irvine, California and 1 other locations · NCT07735533

• Rocbrutinib and Lacutoclax in B-cell cancers

  This study tests whether Rocbrutinib plus Lacutoclax can help adults with B-cell malignancies, including CLL/SLL, MCL, DLBCL, FL, WM, who have had prior therapy or are treatment-naïve under specific criteria.

  Recruiting Phase 1/2 Guangzhou Lupeng Pharmaceutical Company LTD. · Tianjin · NCT07609862

• Polatuzumab vedotin with Zanubrutinib, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone in untreated DLBCL (MCD/BN2/N1)

  This study tests a targeted combination therapy to see if it can treat previously untreated DLBCL with specific molecular subtypes.

  Recruiting Phase 2 The First Affiliated Hospital with Nanjing Medical University · Nanjing, Jiangsu · NCT07608978

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.