The purpose of this study is to assess the efficacy and safety of APG-2575 single agent in patients with relapsed/refractory CLL/SLL.
This is an single-arm, open-label, multi-center, pivotal registration Phase II study of efficacy and safety of APG-2575 as a single agent in relapsed/refractory CLL/SLL patients. This study plans to enroll approximately 75 CLL/SLL subjects who have failed or are intolerant to prior immunochemotherapy and BTK inhibitor therapy. Eligible subjects will receive APG-2575 600mg, orally administered once daily (QD), within half an hour of a low-fat meal, for a cycle of 28 days. Participants will continue to accept APG - 2575 until the "end of treatment" that are consistent with the provisions in the solution of the termination of any specified standards.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
75
APG-2575 orally once daily at 600mg dose levels, every 28 days as a cycle.
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGZhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Objective Response Rate (ORR)
ORR is defined by Complete Remission (CR)+ CR with incomplete marrow recovery (CRi) + Partial Remission (PR) (according to NCI-WG CLL(2018)) and by CR+PR ( according to Lugano (2014)).Response will be evaluated every 2 cycles (8 weeks) till complete treatment or one month after last dose.
Time frame: Up to 9 months after the last subject enrolled.
Progress Free Survival (PFS)
PFS is defined as the time from the first administration to disease progression(PD) or death from any cause.
Time frame: Up to 9 months after the last subject enrolled.
Time To Progression (TTP)
TTP is defined as the time from the first administration to PD.
Time frame: Up to 9 months after the last subject enrolled.
Time To Response (TTR)
TTR is defined as the time from the first administration to the subjects' first CR, CRi, or PR.
Time frame: Up to 9 months after the last subject enrolled.
Duration of Response (DOR)
DOR is defined as the time from the subject's first CR, CRi, or PR to PD or death from any cause.
Time frame: Up to 9 months after the last subject enrolled.
Overall Survival (OS)
OS is defined as the time from the first administration to death.
Time frame: Up to 9 months after the last subject enrolled.
the time of half absolute lymphocyte value (ALC)
The time of half absolute lymphocyte value (ALC) is defined as the time from the first administration to 50% reduction of ALC of baseline.
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Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
RECRUITINGHainan General Hospital
Haikou, Hainan, China
NOT_YET_RECRUITINGHenan Cancer Hospital
Zhengzhou, Henan, China
RECRUITINGUnion Hospital medical college Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGThe First Affilated Hospital of Soochow University
Suzhou, Jiangsu, China
NOT_YET_RECRUITINGPeople's hospital of Jiangsu Province
Suzhou, Jiangsu, China
NOT_YET_RECRUITINGThe First Affilated Hospital of Nanchang University
Nanchang, Jiangxi, China
NOT_YET_RECRUITINGInstitute of blood transfusion of Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China
NOT_YET_RECRUITING...and 1 more locations
Time frame: Up to 9 months after the last subject enrolled.
Adverse events
Adverse events (AE) and serious adverse events (SAE) will be graded according to NCI CTCAE Version 5.0.
Time frame: Up to 9 months after the last subject enrolled.
Maximum plasma concentration (Cmax)
Maximum plasma concentration (Cmax) will be assessed on all participants with APG-2575 treatments.
Time frame: Up to 4 cycles (each cycle is 28 days).
Area under the plasma concentration versus time curve (AUC)
Area under the plasma concentration versus time curve (AUC) will be assessed on all participants with APG-2575 treatments.
Time frame: Up to 4 cycles (each cycle is 28 days).