Study of APG-2575 in Patients With Relapsed/Refractory CLL/SLL
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAscentage Pharma Group Inc.
About this trial
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
This trial does not accept healthy volunteersQualifiers
Age ≥18 years old.
Pathologically confirmed CLL/SLL according to the 2018 revised IWCLL NCI-WG guidelines, subject with measurable lesions or splenomegaly due to CLL.
Expected survival is at least 12 weeks.
Refractory, recurrent, or intolerant to BTK inhibitors and immunochemotherapy,or first-line treatment with BTK inhibitors fails and is not suitable for immunochemotherapy.
Disqualifiers
Prior history of allogeneic hematopoietic stem cell transplantation, adoptive cell immunotherapy or autologous hematopoietic stem cell transplantation within 24 months.
Failure to recover adequately, at the discretion of the investigator, from prior surgical procedures. Patients who have had major surgery within 28 days from study entry, and patients who have had minor surgery within 14 days of study entry.
Received Bcl-2 inhibitor treatment.
Invasive NHL transformation or central nervous system (CNS) involvement has occurred.
Trial design
Design model
Single group
Treatments tested in this trial
APG2575
DrugAPG-2575 orally once daily at 600mg dose levels, every 28 days as a cycle.
Treatment groups
75 Participants
are divided into 1 treatment groupGroup A: APG-2575 single agent in Relapse/Refractory CLL/SLLExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.Secondary outcomes
1
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.2
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.3
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.4
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.Other outcomes
1
Minimal Residual Disease (MRD) negative rate
To observe the proportion of subjects with MRD negative status in bone marrow, peripheral blood, one or both.
Time frame
Up to 9 months after the last subject enrolled.2
Bcl-2 expression
Potential biomarkers to be evaluated included the association of Bcl-2 expression with the efficacy of APG-2575 monotherapy.
Time frame
Up to 9 months after the last subject enrolledSponsors and contacts
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Source ClinicalTrials.gov