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

Soochow University

Status and phase: Active, not recruiting; Phase 2

Conditions: Relapsed Adult AML; Refractory Acute Leukemia; Acute Myeloid Leukemia

Treatments: Drug: CAHAG regimen; Drug: Placebo regimen

Study type: Interventional

Funder types: Other

Identifiers

NCT05029141

SZCAHAG

Details and patient eligibility

About

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

Enrollment: 21 patients

Sex: All

Ages: 18 to 69 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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21 participants in 2 patient groups, including a placebo group

Chidamide+AZA+HHT+AraC+G-CSF group

Experimental group

Description:

The patients are randomized into the group. Patients whose last induction failure regimen is a demethylated agent combined with priming regimen enter the experimental group directly.

Treatment:

Drug: CAHAG regimen

Placebo+AZA+HHT+AraC+G-CSF group

Placebo Comparator group

Description:

The patients are randomized into the group.

Treatment:

Drug: Placebo regimen