Single Arm Study of Azacitidine and Venetoclax for Treatment of Newly Diagnosed Fit Acute Myeloid Leukemia Patients

• Status: Not yet recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this clinical research study is to evaluate the safety and efficacy of Azacytidine in combination with Venetoclax in patients with newly diagnosed fit acute myeloid leukemia.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhujiang Hospital
• Treatments: Azacitidine; Venetoclax

Criteria

Inclusion Criteria:

• 1.Age 45 to 65 years old,both male and female

• 2.Be able to understand and sign informed consent

• 3.Untreated AML patients (non-APL) diagnosed according to the 2016 World Health Organization (WHO) classification and diagnostic criteria for acute myeloid leukemia

• 4.Patients with an ECOG performance status 0,1,2 or 3

• 5.Expected survival time≥3 months

• 6.Laboratory indicators meet the following standards:

1. Bilrubin, ALT and AST were all less than 3 times the upper limit of normal within 7 days before the first day of treatment

2. Serum creatinine clearance rate is greater than 30ml/min

Exclusion Criteria:

• 1.patients participating in other interventional or observational clinical studies currently

• 2.Patients has a history of myeloproliferative neoplasm [MPN]

• 3.Patients with acute promyelocytic leukemia

• 4.Active CNS involvement in patients with acute myeloid leukemia

• 5.Patients with active hepatitis B or C, HIV infection before enrollment

• 6.Cardiovascular status of patients evaluate by NYHA classification method > 2

• 7.Patients have chronic respiratory disease requiring continuous oxygen treatment, or any sitiuation investigator believes will adversely affect this study (including renal, neurological, psychiatric, endocrine, metabolic, immune, hepatic, cardiovascular disease and known history of allergy to any study drug)

• 8.Patients suffering from malabsorption syndrome or other diseases that prevent the enteral route of administration

• 9.patients present with an uncontrolled systemic infection (viral, bacterial, or fungal)

• 10.Patients with a history of other malignancies within 2 years before enrollment, except for the following cases:

1. Adequately treated carcinoma in situ of the cervix or carcinoma of the breast

2. Basal cell carcinoma or localized squamous cell carcinoma of skin