ClinicaliQ Trial Snapshot
- Quizartinib or Placebo Plus Chemotherapy in Newly Diagnosed Patients With FLT3-ITD Negative AML — Recruiting • Phase III • Oncology • NCT06578247.
- What is being tested: Quizartinib (a FLT3 inhibitor) plus standard chemotherapy versus placebo plus chemotherapy in newly diagnosed FLT3-ITD negative AML patients to determine whether targeted FLT3 inhibition improves treatment outcomes in this molecularly-defined subgroup.
- Patient eligibility overview: The trial enrolls patients with newly diagnosed AML who are FLT3-ITD negative (lacking the internal tandem duplication mutation), representing approximately 70% of AML cases and a population where FLT3-directed therapy has not yet been established as standard care.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
This study will compare the effects of Quizartinib versus placebo in combination with chemotherapy in participants with newly diagnosed FMS-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) negative acute myeloid leukemia (AML).
Eligibility Snapshot
- Key Inclusion Criteria: 1. 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. 2. ≥18 years or the minimum legal adult age (whichever is greater) and ≤70 years (at Screening). 3. Newly diagnosed, morphologically documented primary AML based on the World Health Organization (WHO) 2016 classification (at Screening) 4. 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 Key
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.