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A observational clinical study valuating the effectiveness and safety of venetoclax combined with azacytidine and harringtonolide in the treatment of newly diagnosed elderly acute myeloid leukemia patients

A observational clinical study valuating the effectiveness and safety of venetoclax combined with azacytidine and harringtonolide in the treatment of newly diagnosed elderly acute myeloid leukemia patients

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200058248
Enrollment
Unknown
Registered
2022-04-03
Start date
2022-04-01
Completion date
Unknown
Last updated
2023-12-10

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

Conditions

acute myeloid leukemia (non-APL)

Interventions

None listed

Sponsors

Shanxi Bethune Hospital of Shanxi Medical University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
60 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with AML (non-APL) according to the WHO criteria (2016 version), who have not been treated before except hydroxyurea. AML patients include de novo AML, AML evolved from MDS or other AHD, and AML after previous cytotoxic therapy or radiation (secondary AML). Eligible patients with AML caused by a prior hematologic disorder (AHD) including MDS may have been treated for a prior hematologic disorder (other than an allogeneic transplant); 2. Bone marrow morphology or molecular level excludes acute promyelocytic leukemia (APL); 3. Age = 60 years, male or female; 4. Obtain the informed consent signed by the patient or legal representative.

Exclusion criteria

Exclusion criteria: 1. Acute promyelocytic leukemia, myeloid sarcoma, accelerated phase and blast phase of chronic myeloid leukemia; 2. Patients with relapsed AML; 3. Allergies to any of the drugs involved in the program; 4. Pregnant, lactating women and patients of childbearing age who are unwilling to take contraceptive measures; 5. Suffering from other malignant tumors that need to be treated at the same time; 6. AIDS patients, syphilis patients, active hepatitis B (HBV-DNA can be detected) and hepatitis C patients; 7. Any concurrent medical conditions or diseases that may interfere with the research procedures or results, or that the investigators judge will bring certain risks to participation in this research (such as active systemic infection); 8. Unable to understand or follow the research protocol; 9. Received major surgery within 4 weeks before randomization; 10. Participate in other clinical researchers at the same time one month before enrollment.

Design outcomes

Primary

MeasureTime frame
Complete Response Rate, CR;Partial Response Rate. PR;safety;—

Countries

China

Contacts

Public ContactRuijuan Zhang

Shanxi Bethune Hospital of Shanxi Medical University

13593169668@163.com+86 13593169668

Outcome results

None listed

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