RecruitingPhase 1Phase 2NCT04494503

Study of APG2575 Single Agent and Combination Therapy in Patients With Relapsed/Refractory CLL/SLL

A Phase Ib/II Study of the Safety, Pharmacokinetic, Pharmacodynamic and Efficacy of APG-2575 Single Agent and in Combination With Other Therapeutic Agents in Patients With Relapsed/Refractory CLL/SLL

Sponsor

Ascentage Pharma Group Inc.

Enrollment

123 participants

Start Date

Aug 31, 2020

Study Type

INTERVENTIONAL

Conditions

Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma

Summary

The purpose of this study is to assess the safety, pharmacokinetic, pharmacodynamic and efficacy of APG-2575 single agent and in combination with other therapeutic agents in patients with relapsed/refractory CLL/SLL.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests APG2575, a drug that blocks a protein called BCL-2 that helps cancer cells survive, either alone or in combination with other therapies, for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that has relapsed or stopped responding to prior treatment. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of CLL or SLL - Your disease has relapsed or become refractory (stopped responding) after prior therapy - You have good performance status (ECOG 0–1) - Your heart rhythm, bone marrow, kidney, and liver function meet the required minimums **You may NOT be eligible if...** - You have never received prior treatment for CLL/SLL - You have a very large lymph node (10cm or longer) without prior sponsor approval - You have significant heart rhythm abnormalities (prolonged QTc interval) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAPG-2575

APG-2575 orally once daily, every 28 days as a cycle.

DRUGRituximab

Rituximab 375mg/m2 ivgtt on C1D8 and 500mg/m2 ivgtt on C2-6D1.

DRUGIbrutinib

Ibrutinib 420mg orally once daily during C1D8-28 and following cycles.

Locations(18)

Peking University Third Hospital

Beijing, Beijing Municipality, China

Chongqing Cancer Hospital

Chongqing, Chongqing Municipality, China

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Guangxi Medical University Affiliated Tumor Hospital

Nanning, Guangxi, China

The Affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, China

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Henan Provincial Oncology Hospital

Zhenzhou, Henan, China

Union Hospital medical college Huazhong University of Science and Technology

Wuhan, Hubei, China

Xiangya Hospital Central South University

Changsha, Hunan, China

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Zhongda Hospital Southeast University

Nanjing, Jiangsu, China

The First affiliated hospital of Soochow University

Suzhou, Jiangsu, China

The First affiliated hospital of Nanchang University

Nanchang, Jiangxi, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Fudan University Zhongshan Hospital

Shanghai, Shanghai Municipality, China

Blood Diseases Hospital Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, China

The First Bethune Hospital of Jilin University

Hangzhou, Zhejiang, China

The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT04494503

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