Gilteritinib with Venetoclax and Azacitidine, then High‑Dose Cytarabine and Gilteritinib Maintenance for Newly Diagnosed FLT3‑ITD AML

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single‑center Phase II, single‑arm trial gives fit adults with newly diagnosed intermediate‑risk FLT3‑ITD AML an induction regimen of gilteritinib, venetoclax, and azacitidine (GVA) aimed at achieving deep molecular remission. MRD is measured using a highly sensitive next‑generation sequencing assay called DeepScan; patients who achieve deep FLT3‑ITD negativity proceed to three cycles of high‑dose cytarabine consolidation with continued gilteritinib. After consolidation, patients with persistent or reemergent FLT3‑ITD are withdrawn while those maintaining deep negativity receive gilteritinib maintenance. Outcomes (remission rates, survival, and safety) are compared against historical controls including patients who received allogeneic transplant to see if a transplant‑sparing pathway is feasible.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Each subject (or their legal representative) must sign an informed consent form (ICF) before any specific study procedures or tests, indicating that he/she understands the purpose and procedures of the study and is willing to participate.
* 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 requirement), with no low-risk or high-risk genetic features as defined by ELN 2022.
* ECOG performance status ≤ 2. Biochemical indicators must be within the following limits within 21 days before randomization and at baseline: ALT and AST ≤ 3× upper limit of normal (ULN); total bilirubin ≤ 3× ULN; serum creatinine ≤ 2× ULN or CrCl ≥ 40 mL/min. LVEF determined by echocardiography is within the normal range (LVEF \> 50%).

Exclusion Criteria:

* Diagnosed with acute promyelocytic leukemia (APL), BCR-ABL positive acute myeloid leukemia, or AML secondary to previous chemotherapy or radiotherapy.
* History of other malignancies, except for adequately treated non-malignant skin melanoma, cured in situ tumors, or other solid tumors that have been treated and have had no evidence of disease for at least 2 years.
* Assessed as unfit for intensive chemotherapy based on the following criteria: ECOG performance status ≥ 2 at screening; severe cardiac diseases (e.g., congestive heart failure requiring treatment, ejection fraction ≤ 50%, or chronic stable angina); severe pulmonary diseases (e.g., DLCO ≤ 65% or FEV1 ≤ 65%); creatinine clearance \< 45 ml/min (calculated by Cockcroft-Gault equation), liver disease with total bilirubin \> 1.5 times the normal upper limit (ULN); any other comorbidities deemed incompatible with intensive chemotherapy by the attending physician.
* Uncontrolled fungal, bacterial, or viral infections.
* Known active clinically relevant liver disease (e.g., active hepatitis B or C); known history of HIV infection (participants should undergo HIV testing before randomization).
* History of allergy to any excipients in gilteritinib tablets.
* Pregnant or breastfeeding women.
* Other conditions deemed unsuitable for this study by the investigator.

Where it's running

• The First Affiliated Hospital, Zhejiang University School of Medicine
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Jie Sun
• Email: jsun1492@zju.edu.cn
• Phone: +8613867439726

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.