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Not yet recruiting NCT07601607

Lisaftoclax Plus Chidamide and Rituximab in Relapsed or Refractory Diffuse Large B-cell Lymphoma

Phase I / Phase II Interventional Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Lisaftoclax, Chidamide, rituximab.
Who it may be relevant to
Registry conditions: Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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）

Overview

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).

Interventions

  • Drug Lisaftoclax
    Lisaftoclax will be administered orally once daily on Days 1-14 of each 21-day cycle for up to 6 cycles. During Cycle 1, a daily dose ramp-up schedule will be used. In the 600 mg cohort, participants will receive 200 mg on Day 1, 400 mg on Day 2, and 600 mg on Day 3, followed by 600 mg once daily on Days 4-14. In the 800 mg cohort, participants will receive 200 mg on Day 1, 400 mg on Day 2, 600 mg on Day 3, and 800 mg on Day 4, followed by 800 mg once daily on Days 5-14. From Cycles 2-6, partici
  • Drug Chidamide
    Chidamide will be administered orally at a dose of 20 mg on Days 1, 4, 8, and 11 of each 21-day cycle for up to 6 cycles.
  • Drug rituximab
    Rituximab will be administered intravenously at a dose of 375 mg/m² on Day 1 of each 21-day cycle for up to 6 cycles.

Primary outcome measures

  • Dose-limiting toxicities (DLTs) (Phase 1b) [Time frame: During the first treatment cycle (21 days)]
  • Maximum tolerated dose (MTD) (Phase 1b) [Time frame: During the first treatment cycle (21 days)]
  • Recommended phase 2 dose (RP2D) (Phase 1b) [Time frame: During the first treatment cycle (21 days)]
  • Objective response rate (ORR) [Time frame: Up to approximately 6 months]
Secondary outcome measures (7)
  • Complete response rate (CRR) [Time frame: Up to approximately 6 months]
  • Duration of response (DOR) [Time frame: Up to 24 months]
  • Disease-free survival (DFS) [Time frame: Up to 24 months]
  • Progression-free survival (PFS) [Time frame: Up to 24 months]
  • Overall survival (OS) [Time frame: Up to 24 months]
  • Incidence of adverse events (AEs) and serious adverse events (SAEs) [Time frame: Up to 30 days after the last study treatment]
  • Change in Quality of Life [Time frame: Up to 24 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Sun yat-sen university cancer center — Guangzhou

Identifiers

NCT: NCT07601607 · B2026-253

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗