OncoMatch/Clinical Trials/NCT07259707
Gilteritinib Plus VA Followed By Consolidation Chemotherapy in Newly Diagnosed FLT3-ITD+ AML
Is NCT07259707 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies GVA + HDAC Consolidation & Gilteritinib Maintenance for acute myeloid leukemia.
Treatment: GVA + HDAC Consolidation & Gilteritinib Maintenance — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Required: FLT3 internal tandem duplication
FLT3-ITD mutation according to the European LeukemiaNet (ELN) 2022 diagnostic criteria (no VAF requirement)
Excluded: BCR fusion
BCR-ABL positive acute myeloid leukemia
Excluded: ABL1 fusion
BCR-ABL positive acute myeloid leukemia
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: chemotherapy
AML secondary to previous chemotherapy or radiotherapy
Cannot have received: radiation therapy
AML secondary to previous chemotherapy or radiotherapy
Lab requirements
Kidney function
serum creatinine ≤ 2× uln or crcl ≥ 40 ml/min
Liver function
alt and ast ≤ 3× uln; total bilirubin ≤ 3× uln
Cardiac function
lvef determined by echocardiography is within the normal range (lvef > 50%)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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