OncoMatch/Clinical Trials/NCT07259707
Gilteritinib Plus VA Followed By Consolidation Chemotherapy in Newly Diagnosed FLT3-ITD+ AML
Is NCT07259707 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
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)
Demographics
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.
Frequently asked questions
Is NCT07259707 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require FLT3?
Yes, FLT3 internal tandem duplication is a required biomarker for enrollment.
Are patients with BCR alterations eligible?
No. BCR fusion is an exclusion criterion.
Are patients with ABL1 alterations eligible?
No. ABL1 fusion is an exclusion criterion.
Is there an age limit?
Yes. Patients must be 59 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages