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Clinical study on efficacy and safety of VA combined with Gilteritinib for treatment of de novo AML with NPM1mut/FLT3/ITDmut/DNMT3Amut

Clinical study on efficacy and safety of VA combined with Gilteritinib for treatment of de novo AML with NPM1mut/FLT3/ITDmut/DNMT3Amut

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500098586
Enrollment
Unknown
Registered
2025-03-11
Start date
2025-03-15
Completion date
Unknown
Last updated
2025-03-17

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

Conditions

De novo AML with NPM1, FLT3/ITD and DNMT3A triple mutations

Interventions

GVA group:VA combined with Gilteritinib regimen

Sponsors

The first affiliated hostipal of nanchang university
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Diagnosed with AML according to WHO2022 criteria; 2.AML patients with concurrent NPM1, FLT3/ITD and DNMT3A mutations; 3.De nove AML, not received other induction therapy (including chemotherapy, demethylation drugs, other targeted drugs) before enrollment (except hydroxyurea); 4.ECOG score 0-2; 5.Liver function: Total bilirubin =30ml/min; 7.Patients must be able to understand and willing to participate in the study and sign an informed consent form;

Exclusion criteria

Exclusion criteria: 1.Acute promyelocytic leukemia; 2.With central nervous system leukemia; 3.Myeloid sarcoma; 4.secondary to treated MDS, MPN or CMML; 5.Uncontrollable active infection; 6.Positive for HBV-DNA or HCV-RNA; 7.HIV infection; 8.Heart failure grade 2 or higher; 9.Pregnant or nursing patients; 10.Patients who refused to enroll in the study; 11.Patients deemed unsuitable for enrollment by the investigators;

Design outcomes

Primary

MeasureTime frame
composite complete remission;

Secondary

MeasureTime frame
overall survival;remission depth;relapse-free survival;

Countries

China

Contacts

Public ContactFancong Kong

The first affiliated hostipal of nanchang university

360035477@qq.com+86 189 7093 4599

Outcome results

None listed

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