The goal of this clinical trial is to treat adult patients with relapsed/refractory acute myeloid leukemia (AML) using a salvage chemotherapy regimen consisting of Sonrotoclax, cladribine, and standard-dose cytarabine, sequentially followed by allogeneic hematopoietic stem cell transplantation (allo-HSCT). The main questions it aims to answer are:
Does this treatment regimen improve the 2-year overall survival (OS) rate, relapse-free survival (RFS) rate, and cumulative incidence of relapse (CIR) in this patient population?
What is the safety profile of this combination and sequential transplant strategy, particularly regarding treatment-related mortality (TRM) and adverse events?
As this is a single-arm phase II study, there is no comparator group.
Participants will:
Receive salvage chemotherapy with cladribine (5 mg/m² on days 1-5), cytarabine (100 mg/m² twice daily on days 1-5), and Sonrotoclax (escalating doses from 40 mg to 320 mg on days 1-14).
Undergo allogeneic hematopoietic stem cell transplantation as a bridge therapy within 1 to 4 weeks after completing chemotherapy.
Potentially receive Sonrotoclax as maintenance therapy after hematopoietic reconstitution post-transplant, at the investigator's discretion.
Undergo regular follow-up visits for clinical assessments, disease monitoring, and survival evaluation.
1.Patients with a confirmed diagnosis of relapsed or refractory acute myeloid leukemia (AML) based on bone marrow morphology, immunophenotyping, and cytogenetics.
2. Patients who are planned to undergo allogeneic hematopoietic stem cell transplantation, including HLA-matched or HLA-mismatched related allogeneic transplantation, as well as unrelated donor transplantation.
3. Age between 18 and 65 years, inclusive, regardless of gender.
4. Eastern Cooperative Oncology Group performance status (ECOG) of 0-2.
1. Uncontrolled active infection (bacterial, fungal, or viral).
2. Known positive serology for human immunodeficiency virus (HIV) or active hepatitis C virus (HCV).
3. Psychiatric disorders or other medical conditions that preclude compliance with the study treatment and monitoring requirements.
4. Pregnant patients, or patients who are unwilling or unable to use adequate contraceptive measures during the treatment period.