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A prospective, multicenter, single-arm clinical study of the efficacy and safety of Venetoclax combined with reduced-intensity chemotherapy (VIA) in newly diagnosed pediatric AML

A prospective, multicenter, single-arm clinical study of the efficacy and safety of Venetoclax combined with reduced-intensity chemotherapy (VIA) in newly diagnosed pediatric AML

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300067686
Enrollment
Unknown
Registered
2023-01-18
Start date
2023-01-18
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

pediatric acute myeloid leukemia

Interventions

Test group:VEN+IA

Sponsors

Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years

Inclusion criteria

Inclusion criteria: 1) <18 years old; 2) Patients diagnosed with non-M3-AML according to the revised WHO criteria in 2022; 3) had not received any systemic treatment for AML before enrollment in this study; 4) Children can swallow tablets. 5) Sign informed consent voluntarily.

Exclusion criteria

Exclusion criteria: 1) Acute promyelocytic leukemia, acute myeloid leukemia associated with Down syndrome, acute heterozygotic leukemia; 2) Sudden change of CML; Secondary to MDS/MPN; Treatment-associated AML; 3) Secondary to immune deficiency or congenital bone marrow depletion disease; 4) Patients with any history of chemotherapy or radiotherapy in the previous 3 months (emergency radiotherapy for relieving symptoms of compression is not included).

Design outcomes

Primary

MeasureTime frame
Complete response rate;

Secondary

MeasureTime frame
MRD;EFS;OS;Adverse reaction;

Countries

China

Contacts

Public ContactZhu Xiaofan

Institute of Hematology, Blood Disease Hospital, Chinese Academy of Medical Sciences

xfzhu@ihcams.ac.cn+86 137 5209 0418

Outcome results

None listed

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