NCT07862517Not yet recruitingPhase 2

Testing the Investigational Medication Combination of Azacitidine, Venetoclax, and Quizartinib Compared to the Usual Treatment of Cytarabine, Daunorubicin, and Quizartinib for Patients With FLT3-ITD Mutant Acute Myeloid Leukemia (A MyeloMATCH Treatment Trial)

A Phase II Randomized Study of Induction Therapy Comparing Cytarabine, Daunorubicin, and Quizartinib vs Azacitidine, Venetoclax, and Quizartinib in FLT3-ITD Mutant Acute Myeloid Leukemia: A MyeloMATCH Substudy

Source: ClinicalTrials.gov · Last updated 7 Oct 2026

Brief summary (registry, in English)

This phase II MyeloMATCH treatment trial compares the combination of azacitidine, venetoclax and quizartinib to the standard treatment of cytarabine, daunorubicin and quizartinib for the treatment of patients with FLT3-ITD mutant acute myeloid leukemia. Azacitidine and quizartinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking BCL-2, a protein needed for cancer cell survival. Chemotherapy drugs, such as cytarabine and daunorubicin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving azacitidine, venetoclax and quizartinib may be more effective than giving cytarabine, daunorubicin and quizartinib for the treatment of patients with FLT3-ITD mutant acute myeloid leukemia.

Status (registry): Not yet recruiting
Phase (registry): Phase 2
Study type: Interventional
Enrollment: 122 (estimated)
First submitted: 5 Oct 2026
Start date: 15 Jan 2027
Primary completion date: 31 Dec 2027
Lead sponsor: National Cancer Institute (NCI)
Diseases: Acute myeloid leukemia
NCT number: NCT07862517

What you commit to

Study type: Interventional · Phase 2
Planned participants: 122
From 15 Jan 2027 to the primary completion date, 31 Dec 2027
No sites listed in no country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

Patient must be ≥ 18 and ≤ 59 years of age
Patient must be assigned to this protocol by the MYELOMATCH Protocol
Patient must have newly diagnosed acute myeloid leukemia (AML) with FLT3 ITD mutation as assessed by central myeloMATCH testing with variant allele frequency (VAF) over 5%
Patient must not have any contraindications to the conventional chemotherapy used in this study
Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Patient must not have Core-binding factor \[inv(16), t(16;16) or t(8;21)\] leukemia
Patient must not have acute promyelocytic leukemia
Patient must not have had prior therapy with deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) for myelodysplastic syndrome (MDS)
Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All patients of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy. A patient of childbearing potential is defined as anyone, regardless of whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
Patient must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study. Contraception measures must continue for:
- 7 months after the last dose of quizartinib for patients of childbearing potential and for 4 months after the last dose of quizartinib for patients who are able to father children
- 6 months after the last dose of daunorubicin for all patients
- 30 days after the last dose of venetoclax for patients of childbearing potential
- 6 months after the last dose of azacitidine for patients of childbearing potential and for 4 months after the last dose of azacitidine for patients who are able to father children In addition, patient must not breastfeed during treatment and for 1 month after treatment ends
Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible
Total bilirubin ≤ 2 x institutional upper limit of normal (ULN). Patients with Gilbert's Syndrome must have total bilirubin ≤ 3 x institutional ULN (labs must be obtained ≤ 7 days prior to protocol randomization)
Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) ≤ 3.0 × institutional ULN (labs must be obtained ≤ 7 days prior to protocol randomization)
Creatinine Clearance (CrCL) ≥ 30 mL/min calculated using the Cockcroft-Gault equation (labs must be obtained ≤ 7 days prior to protocol randomization)
Left ventricular ejection fraction \> 45% (which must be obtained ≤ 2 weeks prior to randomization)
- NOTE: Since quizartinib can increase corrected QT interval (QTc) and many patients will require supportive care agents that affect QTc, a baseline electrocardiogram (ECG) ≤ 2 weeks prior to randomization is recommended if clinically indicated
Patient must not have Common Terminology Criteria for Adverse Events (CTCAE) \> grade 3 hypokalemia, hypomagnesemia, or hypocalcemia. Patients with grade 1-2 electrolyte abnormalities are eligible while electrolytes are being corrected
Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible for this trial
For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
Patients must not have had history of treatment with cardiotoxic agents unless total anthracycline lifetime dose is \< 450 mg/m\^2 doxorubicin equivalents
Patients must not have uncontrolled or significant cardiovascular disease, including any of the following:
- Fridericia's formula-corrected QT (QTcF) interval \> 450 ms;
- Diagnosis of or suspicion of long QT syndrome (including family history of long QT syndrome);
- Systemic blood pressure \> 180 mmHg or diastolic blood pressure \> 110 mmHg;
- History of clinically relevant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes);
- History of second (Mobitz II) or third degree heart block (patients with pacemakers are eligible if they have no history of fainting or clinically relevant arrhythmias while using the pacemaker);
- History of uncontrolled angina pectoris or myocardial infarction within 6 months prior to randomization;
- History of New York Heart Association class 3 or 4 heart failure;
- Complete left bundle branch block
Patient must not require treatment with concomitant strong or moderate CYP3A4 inducers
Patient must not require treatment with concomitant strong CYP3A4 inhibitors (e.g., antifungal azoles) unless considered necessary for the prevention or treatment of infections - in which a quizartinib dose reduction will be required
Patient must not have any known gastrointestinal (GI) disease or prior GI procedure that could interfere with the oral absorption or tolerance of quizartinib or venetoclax, including difficulty swallowing
Patient must not have any uncontrolled intercurrent illness or any other significant condition(s) that would make this protocol unreasonably hazardous

Age in the registry: 18 years to 59 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.