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A prospective multicenter cohort study of Venetoclax combined with DCAG regimen for the treatment of newly diagnosed high-risk acute myeloid leukemia

A prospective multicenter cohort study of Venetoclax combined with DCAG regimen for the treatment of newly diagnosed high-risk acute myeloid leukemia

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400083301
Enrollment
Unknown
Registered
2024-04-19
Start date
2024-05-09
Completion date
Unknown
Last updated
2025-09-08

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

Conditions

Hiigh-risk acute myeloid leukemia

Interventions

Experimental group:Inducing by Venetolcax+DCAG regimen

Sponsors

Peking University People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Newly diagnosed high-risk AML patients: high-risk AML patients (including AML-MR ) were diagnosed according to the NCCN or ELN guidelines 2022, not receiving standard regimen chemotherapy, within 30 days before enrollment; (2) Aged 18 to 65 years old (including 18 and 65); (3) Female patients of childbearing age should receive pregnancy examination before receiving chemotherapy, and must agree to take effective contraceptive measures during the treatment; (4) The subject must sign the informed consent form

Exclusion criteria

Exclusion criteria: Patients who met any of the following exclusion criteria were not enrolled in this trial: (1) The presence of unfit factors as exclusion criteria, at least one of the following conditions: ? past history with congestive heart failure requiring treatment, or ejection fraction= 50% or chronic stable angina pectoris, pulmonary dispersion, carbon monoxide diffusion =65% or forced expiratory volume in one second 65%; or ECOG score of 2 or 3. (2) Any previous demethylated drug therapy or chemotherapy. (3) diagnosed as low-intermedium-risk AML and other hematological malignancies; (4) patients who have received hematopoietic stem cell transplantation; (5) Those with a known allergy to any component of the Venetoclax + DCAG regimen; (6) Those who have attended other clinical trials within 30 days; (7) Pregnant and lactating patients; (8) Patients with known serological tests for HIV; (9) Patients with positive untreated serology for known viral hepatitis; (10) Suffering from mental illness or being unable to meet the requirements of research, treatment and monitoring due to other conditions; (11) Patients who also participate in other clinical studies; (12) Other circumstances unsuitable for inclusion in the opinion of the investigator;

Design outcomes

Primary

MeasureTime frame
CCR rate after 2 course of chemotherapy;disease free survival at 12 month;

Secondary

MeasureTime frame
ORR rate after 1/2 course of chemotherapy;rate of negativity of MRD after 1/2 course of chemotherapy;overall survival at 12 month;

Countries

China

Contacts

Public ContactHao Jiang

Peking University People's Hospital

2516735116@qq.com+86 10 6658 3721

Outcome results

None listed

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