NCT07601607尚未招募1 期
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）
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2026年5月30日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 51
- 试验地点
- 1
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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-
- •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.
排除标准
- •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.
研究者
Qingqing Cai
Professor and Chief Physician
Sun Yat-sen University
研究点 (1)
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