NCT07601607Not yet recruitingPhase 1/2
Lisaftoclax Plus Chidamide and Rituximab in Relapsed or Refractory Diffuse Large B-cell Lymphoma
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）
Source: ClinicalTrials.gov · Last updated 22 May 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 51 (estimated)
- First submitted
- 16 May 2026
- Start date
- 30 May 2026
- Primary completion date
- 30 May 2028
- Lead sponsor
- Sun Yat-sen University
- Diseases
- Diffuse large B-cell lymphoma
- NCT number
- NCT07601607
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 51
- From 30 May 2026 to the primary completion date, 30 May 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Other
- Central nervous system (CNS) involvement by lymphoma, primary CNS lymphoma, or leukemic phase lymphoma.
- Pregnant or breastfeeding women.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sun Yat-sen University Cancer Center Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.