Gilteritinib Plus VA Followed By Consolidation Chemotherapy in Newly Diagnosed FLT3-ITD+ AML

This clinical trial aims to evaluate whether molecular MRD-guided chemotherapy can effectively treat FLT3-ITD mutated AML and potentially replace allogeneic hematopoietic stem cell transplantation. It primarily seeks to answer: * What is the complete remission rate after initial induction with Gilteritinib, Venetoclax, and Azacitidine? * What are the survival rates and safety of subsequent high-dose cytarabine consolidation after two cycles of this induction therapy? As a single-arm study, outcomes will be compared against historical data from standard treatments (including transplant) to ass

Trial Details

NCT ID
NCT07259707
Phase
PHASE2
Sponsor
First Affiliated Hospital of Zhejiang University
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • GVA + HDAC Consolidation & Gilteritinib Maintenance
Locations (sample)
  • Hangzhou, Zhejiang, China|30.29365,120.16142

Key Eligibility Criteria

  • Each subject (or their legal representative) must sign an informed consent form (ICF) before any specific study procedures or tests, indicating tha…
  • Age ≥ 18 years or reaching the legal minimum adult age (whichever is greater) and ≤ 60 years (at screening);
  • Newly diagnosed acute myeloid leukemia with FLT3-ITD mutation according to the European LeukemiaNet (ELN) 2022 diagnostic criteria (no VAF requirem…
  • ECOG performance status ≤ 2. Biochemical indicators must be within the following limits within 21 days before randomization and at baseline: ALT an…

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Leukemia Trials on Trialify →