New Double Epigenetic Regimen in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia

• Status: Recruiting
• Trial end date: 2023-08-31
• Target enrollment: 0
• Participant gender: All

Summary

This study is to investigate the therapeutic efficacy and side effect of chidamide, azacitidine combined with priming HAG regimen for relapsed or refractroy acute myeloid leukemia

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

Details

• Lead Sponsor: The First Affiliated Hospital of Soochow University
• Collaborators: Anhui Provincial Hospital; First Affiliated Hospital of Harbin Medical University; Fujian Medical University Union Hospital; Nanfang Hospital of Southern Medical University; Qilu Hospital of Shandong University; Ruijin Hospital; Shandong Provincial Hospital; The Affiliated Cancer Hospital of Zhengzhou University; The First Hospital of Jilin University; West China Hospital; Xinqiao Hospital of Chongqing

Criteria

Inclusion Criteria:

• Adults aged ≥ 18 and ≤ 70 years

• Patients diagnosed with AML according to 2016 WHO myeloid malignant disease diagnosis standard (Non-APL)

• Patients with AML must meet one of the following criteria, A or B:

A: Refractory AML disease was defined as follows: (1) failure to attain CR following exposure to at least 2 courses of standard or intensive induction therapy; or (2) bone marrow leukemia cell decline index (BMCDI) < 50% and > 20% after 1 course of standard or intensive induction therapy. B: Relapsed AML disease was defined as follows: (1) reappearance of leukemic blasts in the peripheral blood after CR; or (2) detection of ≥ 5% blasts in the BM not attributable to another cause (e.g., BM regeneration after consolidation therapy); or (3) extramedullary relapse.

• ECOG performance status score less than 3

• Expected survival time ˃ 3 months

• Patients without serious heart, lung, liver, or kidney disease

• Ability to understand and voluntarily provide informed consent

Exclusion Criteria:

• Patients who are allergic to the study drug or drugs with similar chemical structures

• Pregnant or lactating women, and women of childbearing age who do not want to practice effective methods of contraception

• Active infection

• Active bleeding

• Patients with new thrombosis, embolism, cerebral hemorrhage, or other diseases or a medical history within one year before enrollment

• Patients with mental disorders or other conditions whereby informed consent cannot be obtained and where the requirements of the study treatment and procedures cannot be met

• Liver function abnormalities (total bilirubin > 1.5 times the upper limit of the normal range, ALT/AST > 2.5 times the upper limit of the normal range or patients with liver involvement whose ALT/AST > 1.5 times the upper limit of the normal range), or renal anomalies (serum creatinine > 1.5 times the upper limit of the normal value)

• Patients with a history of clinically significant QTc interval prolongation (male > 450 ms; female > 470 ms), ventricular heart tachycardia and atrial fibrillation, II-degree heart block, myocardial infarction attack within one year before enrollment, and congestive heart failure, and patients with coronary heart disease who have clinical symptoms and requiring drug treatment

• Surgery on the main organs within the past six weeks

• Drug abuse or long-term alcohol abuse that would affect the evaluation results

• Patients who have received organ transplants (excepting bone marrow transplantation)

• Patients not suitable for the study according to the investigator's assessment