Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Conditions
Keywords
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, APG-2575, Lisaftoclax
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.
Detailed description
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.
Interventions
DRUGAPG2575
APG-2575 orally once daily at 600mg dose levels, every 28 days as a cycle.
Sponsors
Ascentage Pharma Group Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | Up to 9 months after the last subject enrolled. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progress Free Survival (PFS) | Up to 9 months after the last subject enrolled. | PFS is defined as the time from the first administration to disease progression(PD) or death from any cause. |
| Time To Progression (TTP) | Up to 9 months after the last subject enrolled. | TTP is defined as the time from the first administration to PD. |
| Time To Response (TTR) | Up to 9 months after the last subject enrolled. | TTR is defined as the time from the first administration to the subjects' first CR, CRi, or PR. |
| Duration of Response (DOR) | Up to 9 months after the last subject enrolled. | DOR is defined as the time from the subject's first CR, CRi, or PR to PD or death from any cause. |
| Overall Survival (OS) | Up to 9 months after the last subject enrolled. | OS is defined as the time from the first administration to death. |
| the time of half absolute lymphocyte value (ALC) | Up to 9 months after the last subject enrolled. | The time of half absolute lymphocyte value (ALC) is defined as the time from the first administration to 50% reduction of ALC of baseline. |
| Adverse events | Up to 9 months after the last subject enrolled. | Adverse events (AE) and serious adverse events (SAE) will be graded according to NCI CTCAE Version 5.0. |
| Maximum plasma concentration (Cmax) | Up to 4 cycles (each cycle is 28 days). | Maximum plasma concentration (Cmax) will be assessed on all participants with APG-2575 treatments. |
| Area under the plasma concentration versus time curve (AUC) | Up to 4 cycles (each cycle is 28 days). | Area under the plasma concentration versus time curve (AUC) will be assessed on all participants with APG-2575 treatments. |
Countries
China
Contacts
CONTACTZi Chen, Doctor
CONTACTMin Yu, Doctor
STUDY_DIRECTORYifan Zhai, M.D., Ph.D.
Ascentage Pharma Group Inc.
PRINCIPAL_INVESTIGATORJianyong Li, M.D.
The First Affiliated Hospital with Nanjing Medical University
Outcome results
None listed