Clinical Study of Venetoclax Combined With CACAG Regimen in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia

• Status: Recruiting
• Trial end date: 2026-01-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the efficacy and safety of venetoclax combined with CACAG regimen with BAT regimen in the treatment of relapsed/refractory acute myeloid leukemia.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese PLA General Hospital
• Collaborators: Air Force Military Medical University, China; First Hospital of China Medical University; People's Liberation Army (PLA) Strategic Support Force Characteristic Medical Center; The 940th Hospital of Joint Logistics Support Force of Chinese People's Liberation Army; The 960th Hospital of Joint Logistics Support Force of Chinese People's Liberation Army; The General Hospital of Northern Theater Command; The General Hospital of Western Theater Command; Yantai Yuhuangding Hospital
• Treatments: Aclacinomycins; Azacitidine; Cytarabine; Lenograstim; Venetoclax

Criteria

Inclusion Criteria:

• Patients who are able to understand and willing to sign the informed consent form (ICF).

• All patients should aged 14 to 75 years,no gender limitation.

• Patients with R/R AML, diagnosed in accordance with the 2021 edition of the CMA criteria

• Liver function: ALT and AST≤2.5 times the upper limit of normal ,bilirubin≤2 times the upper limit of normal;

• Renal function: creatinine ≤the upper limit of normal;

• Patients without any uncontrolled infections , without organ dysfunction or without severe mental illness;

• The score of Eastern Cooperative Oncology Group (ECOG) is 0-3,and the predicted survival ≥ 4 months.

• Patients without severe allergic constitution.

Exclusion Criteria:

• Patients with allergy or contraindication to the study drug;

• Female patients who are pregnant or breast-feeding.

• Patients with a known history of alcohol or drug addiction on the basis that there could be a higher risk of non-compliance to study treatment;

• Patients with mental illness or other states unable to comply with the protocol;

• Less than 6 weeks after surgical operation of important organs.

• Liver function: ALT and AST>2.5 times the upper limit of normal ,bilirubin>2 times the upper limit of normal;Renal function: creatinine >the upper limit of normal;

• The patient is not suitable for this clinical trial (poor compliance, substance abuse, etc.)