Efficacy and Safety of Lisaftoclax (APG-2575) Monotherapy in Patients With Mature B-cell Lymphoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHenan Cancer Hospital
About this trial
This is a multicenter, prospective, single-arm phase II study designed to evaluate the safety and efficacy of lisaftoclax (APG-2575), an oral selective BCL-2 inhibitor, in patients with indolent B-cell lymphomas. The study will enroll adult patients with chronic lymphocytic leukemia (CLL), Waldenström macroglobulinemia (WM), or marginal zone lymphoma (MZL) who are either treatment-naïve but considered ineligible for Bruton tyrosine kinase (BTK) inhibitor therapy due to significant comorbidities, or who are intolerant to prior BTK inhibitor treatment.
Eligible patients will receive oral lisaftoclax once daily with a dose ramp-up to a target dose of 600 mg in 28-day cycles. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or completion of the planned treatment period. The primary objective is to evaluate the safety and tolerability of lisaftoclax monotherapy, while secondary objectives include assessment of antitumor activity, including overall response rate (ORR), complete response (CR) rate, minimal residual disease (MRD) negativity, progression-free survival (PFS), duration of response (DOR), and overall survival (OS). Quality of life will also be assessed using the EORTC QLQ-C30 questionnaire.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years at the time of signing the informed consent form (ICF).
Hemoglobin (Hb) ≥ 70 g/L (without transfusion support within 7 days prior to the first dose of study drug).
Absolute neutrophil count (ANC) ≥ 0.5 × 10⁹/L (independent of growth factor support within 7 days prior to the first dose of study drug).
Platelet count ≥ 50 × 10⁹/L (without transfusion support within 7 days prior to the first dose of the study drug. If the patient has documented bone marrow involvement, a platelet count ≥ 30 × 10⁹/L is acceptable, provided the investigator ensures adequate supportive care).
Disqualifiers
Prior treatment with any B-cell lymphoma 2 (BCL-2) inhibitor.
Patients with active infection (including active hepatitis B virus [HBV] or hepatitis C virus [HCV] infection, or human immunodeficiency virus [HIV] positivity) or any other serious uncontrolled medical condition (Patients who are hepatitis B surface antigen (HBsAg) positive or hepatitis B core antibody (HBcAb) seropositive are eligible if their HBV DNA is below the lower limit of detection/quantification and they are willing to undergo monthly HBV reactivation monitoring. Patients who are HCV antibody positive are eligible if their HCV RNA is below the lower limit of detection/quantification).
Presence of other concurrent malignancies (except for those specified in the inclusion criteria) that may affect the interpretation of study results or treatment with the investigational drug, or patients with severe coagulation disorders, or severe impairment of cardiac, cerebral, pulmonary, hepatic, or renal function.
History of deep vein thrombosis (DVT) or pulmonary embolism (PE) within 12 months prior to the first dose of the study drug.
Trial design
Design model
Single group
Treatments tested in this trial
Lisaftoclax
DrugContinuous Monotherapy
Treatment groups
75 Participants
are divided into 1 treatment groupGroup A: Lisaftoclax MonotherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
safety and tolerance
events (AEs) and serious adverse events (SAEs), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
Time frame
From the first dose to within 30 days after the last dose.Secondary outcomes
1
Overall Response Rate (ORR)
The proportion of patients achieving complete response (CR) or partial response (PR) according to disease-specific response criteria (IWCLL 2018 for CLL, IWWM-6 for WM, and Lugano 2014 criteria for MZL).
Time frame
Up to 24 months2
Complete Response Rate (CR)
The proportion of patients achieving complete response according to disease-specific response criteria.
Time frame
Up to 24 months3
Minimal Residual Disease (MRD) Negativity Rate
The proportion of patients achieving minimal residual disease negativity assessed by flow cytometry.
Time frame
Up to 24 months4
Progression-Free Survival (PFS)
Time from first dose of study treatment to disease progression or death from any cause.
Time frame
Up to 24 monthsSponsors and contacts
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Source ClinicalTrials.gov
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