A prospective clinical study evaluating the efficacy and safety of a venetoclax-based quadruple combination regimen in newly diagnosed patients with high risk AML

A single-center, single-arm, prospective clinical study evaluating the efficacy and safety of a venetoclax-based quadruple combination regimen in newly diagnosed patients with high risk acute myeloid leukemia

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2600122889

Enrollment

Unknown

Registered

2026-04-20

Start date

2026-04-20

Completion date

Unknown

Last updated

2026-04-27

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:Four-drug combination therapy

Eligibility

Sex/Gender

All

Age

18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Age >= 18 years; expected survival time >= 3 months; 2. ECOG score 0-2; 3. Women of childbearing potential must have a negative pregnancy test and be willing to use effective contraception during the study period and for >=12 months after the last dose. Male participants must use effective contraception during the study period and for >=3 months after the last dose; 4. Intact hepatic and renal function (creatinine <= 1.5 × ULN, BUN <= 1.5 × ULN, ALT <= 2 × ULN, AST <= 2 × ULN, total bilirubin <= 1.5 × ULN). 5. Voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Central nervous system leukemia; 2. Acute promyelocytic leukemia (M3); 3. Developing other malignant tumors within 5 years; 4. Presence of active viral or bacterial infection not adequately controlled by appropriate antimicrobial therapy. 5. Positive serology for HIV. 6. Presence of psychiatric disorders or other conditions that preclude compliance with the requirements of study treatment and monitoring. 7. Patients with uncontrolled cardiac disease. 8. Resence of bone marrow fibrosis of grade 2 or 3. 9. Other conditions that, in the investigator's judgment, make the subject unsuitable for participation in this clinical trial.

Design outcomes

Primary

Measure	Time frame
Composite complete remission rate(CRc);	—

Secondary

Measure	Time frame
Overall Response Rate (ORR);MRD negative rate;Partial Response (PR);Myelosuppression;Duration of Response (DOR);Gastrointestinal Toxicity;Overall Survival (OS);Cytogenetic Response;Event free survival;Treatment-Related Infection;Disease free survival;	—

Countries

China

Contacts

Public ContactHongyan Tong

The FIrst Affiliated Hospital, College of Medicine, Zhejiang University

hongyantong@aliyun.com+86 571 87236625

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 1, 2026