Efficacy and safety of chemotherapy using homoharringtonine combined with Venetoclax in the treatment of AML and high-risk MDS: a prospective, multi-center clinical study

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400080047

Enrollment

Unknown

Registered

2024-01-18

Start date

2024-01-25

Completion date

Unknown

Last updated

2024-01-22

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

Conditions

AML and high-risk MDS

Interventions

experimental group:homoharringtonine combined with Venetoclax was used to induce remission chemotherapy and consolidation chemotherapy, specifically Homoharringtonine 2mg, d 1-14, intravenous drip onc

Venetoclax 400mg, d 1-14, oral administration once a day.

Eligibility

Sex/Gender

All

Age

60 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1: AML and high-risk MDS was clearly diagnosed according to WHO criteria 2: Aged 60 years or older 3: ECOG physical condition score was <= 3 4: No serious complications, such as liver failure, renal failure, heart failure 5: Must be able to understand the protocol, follow medical instructions and sign informed consent

Exclusion criteria

Exclusion criteria: Patients with any of the following criteria were not eligible for this study: 1: Who is receiving either a chemotherapy regimen or a targeted drug 2: Major surgery (excluding diagnostic surgery) performed within the past 4 weeks 3: Evidence of central nervous system disease 4: Active infectious diseases, such as HBV, HCV, tuberculosis 5: Serious diseases that may limit patients' participation in the trial (such as progressive infection, uncontrolled diabetes, severe cardiac insufficiency or myocardial infarction, liver and kidney dysfunction, etc) 6: Participating in other clinical trials or participating in clinical trials of other drugs within 3 months 7: There are allergies or contraindications to any of the drugs involved in the protocol 8: Unable to understand the experimental protocol, follow the doctor's advice, or refuse to sign the informed consent 9: The researchers say it is not appropriate for patients who are treated with this regimen

Design outcomes

Primary

Measure	Time frame
remission rate( CR+CRi);	—

Secondary

Measure	Time frame
Drug safety;	—

Countries

China

Contacts

Public ContactJinsong Yan

Second Hospital of Dalian Medical University

yanjsdmu@126.com+86 177 0987 1028

Outcome results

None listed

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