Multicenter controlled clinical study of VACAG regimen in the treatment of elderly high-risk MDS and acute myeloid leukemia

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2600120998

Enrollment

Unknown

Registered

2026-03-24

Start date

2026-03-31

Completion date

Unknown

Last updated

2026-03-30

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

Conditions

high-risk MDS and acute myeloid leukemia

Interventions

Control group:AML adopts 3+7 chemotherapy regimen, MDS adopts VA regimen

Test group:VACAG chemotherapy regimen was adopted

Eligibility

Sex/Gender

All

Age

60 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Newly diagnosed patients with AML or higher-risk MDS meeting the WHO 2022 criteria; 2. Aged 60 to 85 years, regardless of sex; 3.Eastern Cooperative Oncology Group (ECOG) performance status: 0-2, or patients with an Activities of Daily Living (ADL) score indicating fitness for intensive chemotherapy (refer to Appendix Table 1); 4.Normal cardiac function, with left ventricular ejection fraction >= 50%. 5.Patients fully understand the study, participate voluntarily, and have signed the informed consent form (ICF).

Exclusion criteria

Exclusion criteria: 1. Acute promyelocytic leukemia with the PML-RARA fusion gene; 2.AML with the *BCR/ABL1* mutation or chronic myeloid leukemia in myeloid blast crisis; 3.Evidence of central nervous system leukemia prior to treatment; 4. Patients with relapsed AML; 5. Concomitant malignancy of other organs (requiring treatment); 6.Pregnant or breastfeeding women; 7.Severe, uncontrolled active infection; 8.Severe cardiac disease; 9. Moderate to severe hepatic insufficiency (moderate to severe hepatic insufficiency according to the Child-Pugh classification); 10.Severe renal insufficiency (e.g., Ccr <= 29 mL/min or requiring hemodialysis); 11.Positive HIV serum antibody; 12.Patients deemed by the investigator to be unsuitable for enrollment.

Design outcomes

Primary

Measure	Time frame
CR/CRi rate and Molecular Residual Disease negative rate in two courses of treatment.;Disease-Free Survival and Overall Survival after 4 courses of treatment;Hematologic Improvement, Progressive Disease, Event-Free Survival, Progression-Free Survival, Objective Response Rate, and Overall Survival after 4 treatment courses;	—

Secondary

Measure	Time frame
Incidence of infection;Mortality within 60 days;	—

Countries

China

Contacts

Public ContactKaixun Hu

The seventh medical center of the Chinese People's Liberation Army General Hospital

hukaixun307@163.com+86 136 9336 0158

Outcome results

None listed

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