A study on the efficacy and safety of homoharringtonine combined with azacytidine and venetoclax in the treatment of elderly patients with newly diagnosed acute myeloid leukemia

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400091179

Enrollment

Unknown

Registered

2024-10-22

Start date

2023-10-19

Completion date

Unknown

Last updated

2024-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute myeloid leukemia

Interventions

treatment group:homoharringtonine combined with azacytidine and venetoclax

Eligibility

Sex/Gender

All

Age

60 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Elderly patients with newly treated AML (age =60-70 years old); (2) ECOG score 0-2 points; (3) Acute myeloid leukemia (non-acute promyelocytic leukemia) was clearly diagnosed through blood analysis, bone marrow cell morphology analysis, immune analysis, routine karyotype analysis and gene mutation examination. (4) Have not used homoharringtonine, venetoclax, or hypomethylating drugs in the past; (5) No history of malignant tumors (except MDS); no other tumors occurring at the same time; (6) The expected survival period exceeds 12 weeks; (7) Sign the informed consent.

Exclusion criteria

Exclusion criteria: (1) Not suitable for intensive induction chemotherapy. Relevant criteria include: ECOG score of 2-3 points, history of heart disease (congestive heart failure requiring treatment or ejection fraction =50% or chronic stable angina). Pulmonary carbon monoxide diffusion capacity =65% or the forced expiratory volume in 1 second is =65%. Creatinine clearance =30mL/min and 1.5 times and =3.0 times the upper limit of normal. The presence of any other comorbidity that the physician considers inappropriate for routine intensive chemotherapy. (2) Age =70 years old; (3) Have allergic diseases or allergic constitution, and are allergic to homoharringtonine, venetoclax or hypomethylating drugs; (4) Serious diseases of other organs; (5) Patients who have participated in other clinical trials; (6) The researcher believes that there are other factors that are not suitable for inclusion or that affect the subject's participation or completion of the study.

Design outcomes

Primary

Measure	Time frame
Complete remission, CR;Objective relief rate, ORR;adverse event;Overall survival, OS;progression-free survival, PFS;	—

Countries

China

Contacts

Public ContactYan Xiaojing

The First Hospital of China Medical University

yanxiaojing_pp@hotmail.com+86 138 8912 8302

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026