This is a multi-center, prospective, single-arm, phase 2 clinical study conducted in China to evaluate the efficacy and safety of Lisafotoclax combined with Decitabine and Homoharringtonine in patients with acute myeloid leukemia (AML) who have failed or are intolerant to prior treatment with Venetoclax plus Azacitidine. Eligible participants must be at least 18 years old, have a confirmed diagnosis of AML according to WHO 2016 criteria, and have an ECOG performance status of 0-2. Participants will receive oral Lisafotoclax in combination with intravenous Decitabine and Homoharringtonine according to the study protocol. The primary objective is to assess the overall response rate (ORR) after induction treatment. Secondary objectives include evaluating complete remission (CR) rate, event-free survival (EFS), overall survival (OS), and the incidence of adverse events (AEs) and serious adverse events (SAEs). Participants will be followed for up to 12 months after the last patient is enrolled to collect long-term efficacy and safety data. This study has been approved by the Ethics Committee of the Second Affiliated Hospital of Zhejiang University School of Medicine and will be conducted in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice (GCP).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Oral investigational BCL-2 inhibitor, administered in two phases: 1. LDH induction/consolidation phase (28-day cycles): * Cycle 1: 200 mg on day 1, 400 mg on day 2, 600 mg on days 3-28; * Cycle 2 and beyond: 600 mg once daily on days 1-28. 2. LD maintenance phase (28-day cycles): 600 mg once daily on days 1-14.
Intravenous hypomethylating agent, administered at 15 mg/m²/day via intravenous infusion over 3 hours on days 1-3 of each 28-day cycle, used in both LDH induction/consolidation and LD maintenance regimens.
Intraversible alkaloid anti-leukemia agent, administered at 1 mg/m²/day via intravenous infusion over 2 hours on days 1-7 of each 28-day cycle, used exclusively in the LDH induction/consolidation phase of the study.
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Composite Complete Response Rate (CRc)
The proportion of participants who achieve composite complete remission (CRc), defined as the combination of complete remission (CR), complete remission with incomplete hematologic recovery (CRi), and morphologic leukemia-free state (MLFS) after 1-2 cycles of LDH induction/consolidation therapy.
Time frame: Up to 2 cycles of LDH induction/consolidation therapy (approximately 56 days)
Event-Free Survival (EFS)
The time from the first dose of study treatment to the first occurrence of disease progression, relapse, or death from any cause.
Time frame: Up to 12 months after the last patient is enrolled
Complete Response Rate (CR)
The proportion of participants who achieve complete remission (CR), defined as \<5% bone marrow blasts, no evidence of extramedullary disease, and recovery of peripheral blood counts (ANC ≥1.0×10⁹/L, platelets ≥100×10⁹/L) after 1-2 cycles of LDH therapy.
Time frame: Up to 2 cycles of LDH therapy (approximately 56 days)
Overall Response Rate (ORR)
The proportion of participants who achieve any response (CR + CRi + MLFS + partial remission \[PR\]) after 1-2 cycles of LDH induction/consolidation therapy.
Time frame: Up to 2 cycles of LDH therapy (approximately 56 days)
Time to Response (TTR)
The time from the first dose of study treatment to the first documentation of any response (CR, CRi, MLFS, or PR).
Time frame: Up to 2 cycles of LDH therapy (approximately 56 days)
Duration of Response (DOR)
The time from the first documentation of response (CR, CRi, MLFS, or PR) to the first occurrence of disease progression, relapse, or death from any cause.
Time frame: Up to 12 months after the last patient is enrolled
Overall Survival (OS)
The time from the first dose of study treatment to death from any cause.
Time frame: Up to 12 months after the last patient is enrolled
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