Clinical trial · Interventional
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）
NCT07601607CI-TRIAL-00112378not yet recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL) | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chidamide | Drug | — | UNRESOLVED |
| Lisaftoclax | Drug | — | UNRESOLVED |
| rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Lisaftoclax in combination with chidamide and rituximab
- description
- Patients will receive lisaftoclax orally once daily on Days 1-14 of each 21-day cycle for up to 6 cycles, with daily dose ramp-up during Cycle 1. Chidamide will be administered orally at 20 mg on Days 1, 4, 8, and 11 of each cycle, and rituximab will be administered intravenously at 375 mg/m² on Day 1 of each cycle.
- interventionNames
- Drug: Lisaftoclax
- Drug: Chidamide
- Drug: rituximab
Primary outcomes (4)
- measure
- Dose-limiting toxicities (DLTs) (Phase 1b)
- timeFrame
- During the first treatment cycle (21 days)
- description
- DLTs will be assessed during the DLT evaluation period and graded according to NCI CTCAE version 5.0.
- measure
- Maximum tolerated dose (MTD) (Phase 1b)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * Central nervous system (CNS) involvement by lymphoma, primary CNS lymphoma, or leukemic phase lymphoma. * Prior intolerance to BCL-2 inhibitors and chidamide, or disease refractory to or relapsed after treatment with both agents. * Known hypersensitivity to any component of the study drugs or their analogs. * 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. * Clinically significant active cardiovascular disease. * Uncontrolled or clinically unstable infection requiring parenteral antibacterial, antiviral, or antifungal therapy within 7 days before the first dose of study treatment. * Pregnant or breastfeeding women. * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.