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Recruiting Phase 2 NCT05147467

Study of APG-2575 in Patients With Relapsed/Refractory CLL/SLL

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Trial Parameters

Condition Chronic Lymphocytic Leukemia
Sponsor Ascentage Pharma Group Inc.
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 75
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2021-12-28
Completion 2026-12
Interventions
APG2575

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Brief Summary

The purpose of this study is to assess the efficacy and safety of APG-2575 single agent in patients with relapsed/refractory CLL/SLL.

Eligibility Criteria

Inclusion Criteria: Subjects who meet each of the following inclusion criteria are eligible to participate in this study: 1. Age ≥18 years old. 2. Pathologically confirmed CLL/SLL according to the 2018 revised IWCLL NCI-WG guidelines, subject with measurable lesions or splenomegaly due to CLL. 3. Expected survival is at least 12 weeks. 4. Refractory, recurrent, or intolerant to BTK inhibitors and immunochemotherapy,or first-line treatment with BTK inhibitors fails and is not suitable for immunochemotherapy. 5. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS): 0 -2. 6. Ability to understand and willingness to sign a written informed consent form approved by EC committee (the consent form must be signed by the patient prior to any screening or study-specific procedures). 7. Willingness and ability to comply with study procedures and follow-up examination. Exclusion Criteria: Subjects who meet any of the following exclusion criteria are not to be enrolled in this study: 1

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