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Venetoclax combined with homoharringtonine for the treatment of unfit newly diagnosed actue meyloid leukemia: a multicenter, prospective, phase Ib/II study

Venetoclax combined with homoharringtonine for the treatment of unfit newly diagnosed actue meyloid leukemia: a multicenter, prospective, phase Ib/II study

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200060782
Enrollment
Unknown
Registered
2022-06-11
Start date
2022-06-01
Completion date
Unknown
Last updated
2023-03-26

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

Conditions

Actue meyloid leukemia

Interventions

Trial group:homoharringtonine plus venetoclax

Sponsors

Nanfang Hospital of Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients with newly diagnosed unfit acute myeloid leukemia and aged >= 18 years; 2. Sign informed consent form, have the ability to comply with study and follow-up procedures.

Exclusion criteria

Exclusion criteria: 1. Acute promyelocytic leukemia (AML subtype M3); 2. Life expectancy less than 30 days after the therapy; 3. Cardiac dysfunction ( particularly congestive heart failure, unstable coronary artery disease and serious cardiac ventricular arrhythmias requiring antiarrhythmic therapy); 4. Respiratory failure; 5. Hepatic abnormalities, total bilirubin >= 3 times the upper limit of normal (ULN), alanine aminotransferase or aspartate aminotransferase >= 5 times the ULN; 6. Renal dysfunction; Cr < 30 mL/min; 7. Cobination with secondary tumor; 8. Being allergic to the clinical drugs; 9. Patients with pregnancy.

Design outcomes

Primary

MeasureTime frame
Overall response rate;

Secondary

MeasureTime frame
Event-free survival;Overall survival;Relapse;Composite complete remission;Minimal residual disease;

Countries

China

Contacts

Public ContactGuopan Yu

Nanfang Hospital of Southern Medical University

yugpp@163.com+86 15876559968

Outcome results

None listed

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