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Study identifier: NCT07259707 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Acute Myeloid Leukemia · FLT3 Internal Tandem Duplication Positive · Intermediate Risk Acute Myeloid Leukemia  ·  Sponsor: First Affiliated Hospital of Zhejiang University

PhasePhase 2
Planned participants25
Who can joinAll sexes, 18 Years to 59 Years
Healthy volunteersNo

About this study

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 assess if the new strategy is equally or more effective. Participants will: * Undergo three cycles of high-dose cytarabine consolidation after two cycles of induction therapy, contingent upon achieving deep FLT3-ITD molecular remission. * Start Gilteritinib maintenance therapy after consolidation if FLT3-ITD remains detectable, continuing until deep molecular remission is achieved again.

This description comes directly from the study's public registry record.

Talk to the study team

Jie Sun  ·  +8613867439726  ·  jsun1492@zju.edu.cn

Always discuss trial participation with your own doctor first.

Locations (1)

The First Affiliated Hospital, Zhejiang University School of MedicineHangzhou, Zhejiang, ChinaRecruiting

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Source record: clinicaltrials.gov/study/NCT07259707