NCT07139873招募中3 期
A Phase 3, Open-Label, Randomized, Multicenter Study to Evaluate Anti-tumor Efficacy of DZD8586 Versus Investigator's Choice in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Progression free survival (PFS) assessed by Independent Review Committee (IRC)
研究概览
简要总结
This is a phase 3, open-label, randomized, multi-center study assessing the efficacy and safety of DZD8586 versus investigator's choice in participants with chronic lymphocytic leukemia/small lymphocytic lymphoma who have progressed following prior therapy.
Primary objective of this study is to assess the efficacy using progression free survival assessed by independent review committee as primary endpoint. Approximately 250 participants are estimated to be randomized into the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Male and female participants ≥ 18 years of age.
- •ECOG performance status 0-
- •Confirmed diagnosis of relapsed or refractory CLL/SLL with indication for treatment.
- •Adequate bone marrow reserve and organ system functions.
- •Participants willing to comply with contraceptive restrictions.
排除标准
- •Any unresolved > Grade 1 adverse event at the time of starting study treatment.
- •Known or suspected Richter transformation.
- •Known or suspected CNS involvement.
- •Previous or current therapy and comedications meet exclusion criteria.
- •Participants with major cardiovascular disease, active infection, malignancy or uncontrolled systemic disease.
- •Nausea and vomiting not controlled or chronic gastrointestinal diseases, unable to swallow the formulated product or previous bowel resection that would preclude adequate absorption.
- •Women who are breast feeding.
- •History of hypersensitivity to active or inactive excipients of DZD8586 or drugs with a similar chemical structure or class.
研究组 & 干预措施
Investigator's choice
Active Comparator
干预措施: Idelalisib (Drug)
Daily dose of DZD8586 (Birelentinib)
Experimental
干预措施: DZD8586 (Drug)
Investigator's choice
Active Comparator
干预措施: Rituximab (Drug)
Investigator's choice
Active Comparator
干预措施: Bendamustine (Drug)
结局指标
主要结局
Progression free survival (PFS) assessed by Independent Review Committee (IRC)
时间窗: Approximately 36 Months
次要结局
- PFS assessed by investigator(Approximately 36 Months)
- Objective response rate (ORR) by IRC and investigator(Approximately 36 Months)
研究者
研究点 (2)
Loading locations...
相似试验
进行中（未招募）
3 期
A Study of DZD9008 Versus Platinum-Based Doublet Chemotherapy in Local Advanced or Metastatic Non-small Cell Lung Cancer (WU-KONG28)Non-small Cell Lung CancerNCT05668988Dizal Pharmaceuticals324
进行中（未招募）
3 期
Study of Acalabrutinib Versus Chlorambucil Plus Rituximab in Adult Subjects With Previously Untreated Chronic Lymphocytic LeukemiaUntreated Chronic Lymphocytic LeukemiaNCT04075292AstraZeneca155
招募中
3 期
A Study of MRG003 in Combination With Pucotenlimab Versus Chemotherapy in the Treatment of Patients With Recurrent or Metastatic Nasopharyngeal CarcinomaRecurrent or Metastatic Nasopharyngeal CarcinomaNCT06976190Lepu Biopharma Co., Ltd.446
招募中
3 期
ICP-022 Versus Chlorambucil Combined With Rituximab in the Treatment of Untreated CLL/SLLSmall Lymphocytic LymphomaChronic Lymphocytic LeukemiaNCT04578613Beijing InnoCare Pharma Tech Co., Ltd.218
已完成
3 期
A Clinical Study To Evaluate Camrelizumab (SHR-1210) Plus Capecitabine and Oxaliplatin Followed by Sequential Treatment With Camrelizumab Plus Apatinib Mesylate in Advanced or Metastatic Gastric Cancer (GC) or Gastroesophageal Junction Cancer (GEJ) Without Prior Systemic TherapyGastroEsophageal CancerGastric CancerNCT03813784Jiangsu HengRui Medicine Co., Ltd.885