Study of Azacitidine Combined With Homoharringtonie Based Regimens in AML

• Status: Recruiting
• Trial end date: 2022-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Rencent years have witnessed great progress of the treatment of acute myeloid leukemia. However, most patients have poor outcomes following the currently first-line DA(daunorubicin, cytarabine)/IA(Idarubicin, cytarabine) chemotherapy, espiecially for the older patients and those not eligiable for receiving allo-HSCT. Azacitidine (AZA) was listed to methylation of drugs in China in 2018, is currently the only one approved methylation drugs in the treatment of AML(acute myeloid leukemia), in the NCCN guidelines. The homoharringtonie could induce AML(acute myeloid leukemia) cell lines and primary myeloid leukemia cell apoptosis, and the effect was dose dependent. While, HHT could also induce leukemia cells to differentiate into normal state, eventually achieve the goal of treatment, and control the disease. The investigators conducted a clinical study to evaluate the efficacy and safety of the AZA plus HAG(homoharringtonie, cytarabine, G-CSF), HIA(homoharringtonie, Idarubicin, cytarabine)/HDA(homoharringtonie, daunorubicin, cytarabine). This study is aimed to validate the efficacy and safety advantages of the regimens that cotain homoharringtonie and azacitidine, and to determine which regimen would receive more living benefits.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ge Zheng
• Treatments: Azacitidine; Homoharringtonine

Criteria

Inclusion Criteria:

1. Diagnoised with acute myeloid leukemia

2. Meet the criteria of the 2016 WHO classification system(APL were excluded), based on blood cell counting, bone marrow biopsy, and cytogeneic diagnosis

3. Volunteered to sign the informed consent.

Exclusion Criteria:

1. Mental disorders or other conditions that cannot meet the requirements of research, treatment and monitoring

2. Uncontrolled cardiovascular disease

3. Allergic to azacytarine, homoharringtonie, or other drugs of this study

4. Any other conditions considered by the study investgators that are not suitable for participating in this clinical trial.