Clinical trial · Interventional
Study of Azacitidine Combined With Homoharringtonie Based Regimens in AML
Clinical Study of Azacitidine Combined With Homoharringtonie Based Regimens in Acute Myeloid Leukemia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Rencent years have witnessed great progress of the treatment of acute myeloid leukemia (AML). 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)，a hypomethylating agent, targets epigenetic gene silencing by inhibiting gene expression against malignant phenotypes and is currently approved to treat AML based on the NCCN guidelines. The homoharringtonie (HHT) could induce AML 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 demonstrate the efficacy and safety advantages of the regimens that cotain homoharringtonie and azacitidine.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Azacitidine | Drug | Azacitidine | ALIAS |
| Homoharringtonine | Drug | Omacetaxine Mepesuccinate | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Azacitidine plus HAG
- description
- Patients of de novo or relapsed AML(age≥60y or ineligibility to receive intensive chemotherapy) will receive AZA+HAG (homoharringtonie, cytarabine, G-CSF) regiment as induction therapy. After complete remission(CR), the AZA+HAG regimen was further given 4-6 cycles and followed by azacitidine maintenance or until the disease progresses. AZA -Azacitidine HAG -Homoharringtonie, Cytarabine, G-CSF
- interventionNames
- Drug: Homoharringtonine
- Drug: Azacitidine
- type
- EXPERIMENTAL
- label
- Azacitidine plus HIA
- description
- Patients of de novo or relapsed AML(age\<60y or eligible for intensive chemotherapy) will receive AZA +HIA(homoharringtonie, Idarubicin, cytarabine) regiments as introduction therapy. After CR, post-remission therapy will follow with NCCN guidelines. AZA -Azacitidine HIA -Homoharringtonie, Cytarabine, Idarubicin
- interventionNames
- Drug: Homoharringtonine
- Drug: Azacitidine
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDLi J, Huang Y, Hou Y, Gu Y, Song C, Ge Z. High efficacy of azacitidine combined with homoharringtonine, idarubicin, and cytarabine in newly diagnosed patients with AML: A single arm, phase 2 trial. Front Oncol. 2022 Dec 8;12:1069246. doi: 10.3389/fonc.2022.1069246. eCollection 2022. PMID 36568250