OncoMatch/Clinical Trials/NCT06824168
Evaluation of Two Dose Levels of Quizartinib as Maintenance in FLT3-ITD (+) Acute Myeloid Leukemia Patients in Complete Remission
Is NCT06824168 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Quizartinib High Dose and Quizartinib Low Dose for acute myeloid leukemia.
Treatment: Quizartinib High Dose · Quizartinib Low Dose — This clinical two-arm trial is designed to evaluate two doses of quizartinib as maintenance therapy after induction/consolidation in participants with FMS-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) (+) acute myeloid leukemia (AML) in first complete remission (CR) who have not received allogeneic hematopoietic stem cell transplantation (allo-HSCT).
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Biomarker criteria
Required: FLT3 ITD activating mutation (≥0.05 SR or ≥5% VAF)
confirmed FLT3-ITD-positive (≥0.05 SR or ≥5% VAF) activating mutation from initial diagnosis in bone marrow or peripheral blood as determined by a local institution's validated molecular testing
Excluded: BCR ABL fusion
BCR-ABL positive leukemia (i.e., chronic myelogenous leukemia in blast crisis)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: induction therapy
Has received at least one cycle of induction therapy but no more than two to achieve CR1. The induction cycles can be the same regimen or different regimens and may contain conventional agents only (e.g., cytarabine + daunorubicin or idarubicin: "7 + 3" or "5 + 2"), or a combination with FLT3 inhibitors.
Cannot have received: allo-HSCT
Participant had received allo-HSCT as part of AML treatment.
Lab requirements
Blood counts
Complete blood count recovery is required with absolute neutrophil count of more than 1.000 × 10^9/L and platelets more than 100 × 10^9/L (IWG criteria).
Cardiac function
QTcF interval >450 ms (based on average of triplicate ECG at Screening) excluded; diagnosed or suspected congenital long QT syndrome or known family history of congenital long QT syndrome excluded; history of clinically relevant ventricular arrhythmias, such as ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes excluded; bradycardia of less than 50 bpm excluded unless pacemaker; history of second- or third-degree heart block excluded unless pacemaker and no history of fainting or clinically relevant arrhythmia; myocardial infarction within 6 months prior to screening excluded; uncontrolled angina pectoris within 6 months prior to screening excluded; New York Heart Association Class 3 or 4 congestive heart failure excluded; LVEF ≤45% or institutional lower limit of normal excluded; uncontrolled hypertension (resting systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg despite optimal medical management) excluded; complete left or right bundle branch block excluded; severe aortic stenosis excluded.
Complete blood count recovery is required with absolute neutrophil count of more than 1.000 × 10^9/L and platelets more than 100 × 10^9/L (IWG criteria). Uncontrolled or significant cardiovascular disease, including the following: QTcF interval >450 ms, diagnosed or suspected congenital long QT syndrome, history of clinically relevant ventricular arrhythmias, bradycardia <50 bpm unless pacemaker, history of second- or third-degree heart block unless pacemaker and no history of fainting or clinically relevant arrhythmia, myocardial infarction within 6 months prior to screening, uncontrolled angina pectoris within 6 months prior to screening, NYHA Class 3 or 4 congestive heart failure, LVEF ≤45% or institutional lower limit of normal, uncontrolled hypertension (resting systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg despite optimal medical management), complete left or right bundle branch block, severe aortic stenosis.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- John Hopkins School of Medicine · Baltimore, Maryland
- Umass Memorial Health Care Systems · Worcester, Massachusetts
- Roswell Park Cancer Institute · Buffalo, New York
- Weill Cornell · New York, New York
- Westchester Medical College · Valhalla, New York
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