Lisaftoclax with chidamide and rituximab for relapsed or refractory diffuse large B-cell lymphoma
Tests a combination of lisaftoclax, chidamide and rituximab in adults with relapsed or refractory lymphoma.
Plain-language title generated from the registry record
Registry title: Lisaftoclax Plus Chidamide and Rituximab in Relapsed or Refractory Diffuse Large B-cell Lymphoma
Key facts
- Where
- Guangzhou, ChinaSee the site
- Phase
- Phase 1/2
Where in China
- Sun Yat-sen University Cancer CenterGuangzhou, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sun Yat-sen University
- Trial code
- NCT07601607
- Record updated
- 22 May 2026
- Original description
This is a phase 1b/2a, open-label trial to evaluate the safety, pharmacokinetics, and preliminary efficacy of lisaftoclax in combination with chidamide and rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL).Read full original descriptionShow less
A Phase Ib/IIa Clinical Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Lisaftoclax in Combination With Chidamide and Rituximab in Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Patients（CLARITY Trial）
This is a phase 1b/2a, open-label trial to evaluate the safety, pharmacokinetics, and preliminary efficacy of lisaftoclax in combination with chidamide and rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL).
Inclusion: Age ≥18 years; Histologically confirmed diffuse large B-cell lymphoma (DLBCL) according to the 2016 WHO classification with BCL-2 positivity by immunohistochemistry (defined as BCL-2 expression ≥30%); Relapsed or refractory DLBCL after prior treatment with an anthracycline-containing regimen and an anti-CD20 antibody-containing regimen; Received at least one prior line of therapy and considered ineligible for autologous stem cell transplantation (ASCT); Estimated life expectancy ≥3 months; Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; At least one measurable or evaluable lesion according to the Lugano 2014 lymphoma response criteria; Adequate bone marrow, hepatic, and renal function; Ability to understand and willingness to voluntarily sign a written informed consent form.
Exclusion: Prior intolerance to BCL-2 inhibitors and chidamide, or disease refractory to or relapsed after treatment with both agents; Prior allogeneic hematopoietic stem cell transplantation within 6 months before the first dose, active graft-versus-host disease (GvHD), or requirement for immunosuppressive therapy within 28 days prior to study treatment; Uncontrolled or clinically unstable infection requiring parenteral antibacterial, antiviral, or antifungal therapy within 7 days before the first dose of study treatment; Known hypersensitivity to any component of the study drugs or their analogs; Clinically significant active cardiovascular disease; Active human immunodeficiency virus (HIV) infection and/or acquired immunodeficiency syndrome (AIDS); Malabsorption syndrome or other conditions that may interfere with enteral administration or absorption of study drugs; Any other medical, psychiatric, or social condition that, in the investigator's judgment, would make the subject inappropriate for participation in this study; Central nervous system (CNS) involvement by lymphoma, primary CNS lymphoma, or leukemic phase lymphoma; Pregnant or breastfeeding women.