OncoMatch/Clinical Trials/NCT03661307
Quizartinib, Decitabine, and Venetoclax in Treating Participants With Untreated or Relapsed Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome
Official title: A Phase I/II Study of Quizartinib in Combination With Decitabine and Venetoclax for the Treatment of Patients With Acute Myeloid Leukemia (AML)
Is NCT03661307 recruiting? Yes, currently enrolling (Oct 2026). This Phase 1/2 trial studies multiple treatments including Decitabine and Quizartinib for acute myeloid leukemia.
Treatment: Decitabine · Quizartinib · Venetoclax — This phase I/II trial studies how well quizartinib, decitabine, and venetoclax work in treating participants with acute myeloid leukemia or high risk myelodysplastic syndrome that is untreated or has come back (relapsed). Quizartinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as decitabine and venetoclax, 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 quizartinib and decitabine may work better at treating acute myeloid leukemia and myelodysplastic syndrome.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Chemotherapy
Cancer type
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Biomarker criteria
Required: FLT3 itd
Detection of FLT3-ITD mutation or FLT3-ITD/TKD co-mutations in bone marrow and/or peripheral blood samples within 30 days prior to study enrollment
Required: FLT3 itd/tkd co-mutations
Detection of FLT3-ITD mutation or FLT3-ITD/TKD co-mutations in bone marrow and/or peripheral blood samples within 30 days prior to study enrollment
Allowed: TP53 deletion
newly diagnosed AML with poor risk complex karyotype and/or TP53 deletions/mutations equal or younger than 60 year old
Allowed: TP53 mutation
newly diagnosed AML with poor risk complex karyotype and/or TP53 deletions/mutations equal or younger than 60 year old
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: systemic therapy for AML or MDS with >10% blasts — relapsed cohort
For relapsed cohort: Patients who have received at least one prior therapy for AML or for MDS with > 10% blasts will be eligible. Patients may have received up to 4 prior salvages for AML and/or MDS (defined by the IPSS classification).
Cannot have received: quizartinib (quizartinib)
Prior quizartinib use
Lab requirements
Blood counts
White blood cell count < 25 x 10^9/L; potassium, magnesium, and calcium (normalized for albumin) within institutional normal limits
Kidney function
creatinine < 1.8 mg/dl (unless due to leukemia, hemolysis or congenital disorder)
Liver function
Liver transaminases > 3 x ULN (exclusion); SGPT < 2.5 x ULN (inclusion unless due to leukemia, hemolysis or congenital disorder)
Cardiac function
Baseline left ventricular ejection fraction by ECHO or MUGA >= 50%; LVEF <= 50% (exclusion); Impaired cardiac function (QTcF > 450 msec, congenital long QT syndrome, sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes, second or third degree heart block, sustained HR < 50/min, bifascicular block, complete LBBB, MI or unstable angina within 6 months, CHF NYHA class III/IV, atrial fibrillation within 2 weeks)
Liver transaminases > 3 x ULN (exclusion); SGPT < 2.5 x ULN (inclusion unless due to leukemia, hemolysis or congenital disorder); creatinine < 1.8 mg/dl (unless due to leukemia, hemolysis or congenital disorder); White blood cell count < 25 x 10^9/L; potassium, magnesium, and calcium (normalized for albumin) within institutional normal limits; Baseline left ventricular ejection fraction by ECHO or MUGA >= 50%; LVEF <= 50% (exclusion); Impaired cardiac function (QTcF > 450 msec, congenital long QT syndrome, sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes, second or third degree heart block, sustained HR < 50/min, bifascicular block, complete LBBB, MI or unstable angina within 6 months, CHF NYHA class III/IV, atrial fibrillation within 2 weeks)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- M D Anderson Cancer Center · Houston, Texas
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT03661307 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior quizartinib disqualifies patients from enrollment.
Does this trial require FLT3?
Yes, FLT3 itd is a required biomarker for enrollment.
Does this trial require FLT3?
Yes, FLT3 itd/tkd co-mutations is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify