本研究將比較 Quizartinib 與安慰劑聯合化療在新診斷 FMS 樣酪氨酸激酶 3（FLT3）-內部串聯重複（ITD）陰性急性髓系白血病（AML）參與者中的效果。
適應症：Leukemia
收案條件
納入條件
- Must be competent and able to comprehend, sign, and date an Ethics Committee (EC)- or Institutional Review Board (IRB)-approved ICF before performance of any trial-specific procedures or tests.
- ≥18 years or the minimum legal adult age (whichever is greater) and ≤70 years (at Screening).
- Newly diagnosed, morphologically documented primary AML based on the World Health Organization (WHO) 2016 classification (at Screening)
- Eastern Cooperative Oncology Group (ECOG) performance status (at the time the participant signs their ICF) of 0-2.
- Participant is a candidate for standard "7+3" induction chemotherapy regimen as specified in the protocol per investigator assessment
排除條件
- Diagnosis of acute promyelocytic leukemia (APL), French-American-British classification M3 or WHO classification of APL with translocation, t(15;17)(q22;q12), or BCR-ABL positive leukemia (ie, chronic myelogenous leukemia in blast crisis); participants who undergo diagnostic workup for APL and treatment with all-trans retinoic acid (ATRA), but who are found not to have APL, are eligible (treatment with ATRA must be discontinued before starting induction chemotherapy).
- Diagnosis of AML secondary to prior chemotherapy or radiotherapy.
- Diagnosis of AML with known antecedent myelodysplastic syndrome (MDS) or a myeloproliferative neoplasm (MPN) or MDS/MPNs including chronic myelomonocytic leukemia (CMML), atypical chronic myeloid leukemia (aCML), juvenile myelomonocytic leukemia (JMML) and others.
- Participants with newly diagnosed AML with FLT3-ITD mutations (FLT3-ITD \[+\]) present at ≥5% VAF (or ≥0.05 SR) based on a validated FLT3 mutation assay.
- Prior treatment for AML, except for the following allowances prior to Day 1 of chemotherapy:
- Leukapheresis;
- Treatment for hyperleukocytosis with hydroxyurea;
- Cranial radiotherapy for central nervous system (CNS) leukostasis;
- Prophylactic intrathecal chemotherapy
收案條件維持 ClinicalTrials.gov 原始英文登錄資料，實際收案資格以研究團隊的正式評估與受試者同意書為準。資料來源：ClinicalTrials.gov，每兩週自動更新，最後同步：2026年10月8日。