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A single-arm, multicenter phase II clinical study of venetoclax combined with liposomal mitoxantrone and cytarabine as induction therapy in young patients with acute myeloid leukemia (AML)

A single-arm, multicenter phase II clinical study of venetoclax combined with liposomal mitoxantrone and cytarabine as induction therapy in young patients with acute myeloid leukemia (AML)

Status
Recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600129103
Enrollment
Unknown
Registered
2026-07-31
Start date
2025-12-06
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Acute Myeloid Leukemia

Interventions

Trail Group:None

Sponsors

HenanCancerHospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age 18–65 years; 2. Diagnosis of acute myeloid leukemia (AML) according to the WHO 2022 criteria, with no prior chemotherapy; 3. ECOG performance status score 0–2; 4. Liver function: total bilirubin =30 mL/min; 6. Expected survival >=3 months; 7.The subject has signed the informed consent form for investigational medicinal product treatment.

Exclusion criteria

Exclusion criteria: 1. Acute promyelocytic leukemia (APL) 2. Complicated with central nervous system leukemia 3. Confirmed diagnosis of myeloid sarcoma 4. Concurrent active infection considered uncontrollable by the investigator 5. Positive HBV-DNA or HCV-RNA 6. HIV infection 7. Heart failure of grade >= 2 8. Pregnant or lactating patients 9. Patients refusing enrollment in this study 10. Other patients deemed ineligible for enrollment by the investigator

Design outcomes

Primary

MeasureTime frame
Composite Complete Remission Rate;

Secondary

MeasureTime frame
Duration of Remission;MRD-negative rate after 4 cycles of treatment;Event-Free Survival;Overall Survival;Overall Response Rate ;incidence rate of infectionincidence rate of bleeding / bleeding incidence;Volume of blood product transfusion;Incidence of other adverse drug reactions assessed per CTCAE Version 5.0;

Countries

China

Contacts

Public ContactYin Qingsong

Henan Cancer Hospital

jnyinqingsong@163.com+86 371 6558 7358

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026