OncoMatch/Clinical Trials/NCT03661307
Quizartinib, Decitabine, and Venetoclax in Treating Participants With Untreated or Relapsed Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome
Is NCT03661307 recruiting? Yes, currently enrolling (May 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
Cancer type
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Biomarker criteria
Required: FLT3 ITD mutation
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
Patients with newly diagnosed AML with poor risk complex karyotype and/or TP53 deletions/mutations equal or younger than 60 year old
Allowed: TP53 mutation
Patients with 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: none — frontline cohort
For frontline cohort: Patients must be chemonaive, i.e. not have received any chemotherapy (except hydrea or 1-2 doses of ara-C for transient control of hyperleukocytosis) for AML or MDS.
Must have received: any prior 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
Kidney function
creatinine < 1.8 mg/dl
Liver function
total bilirubin < 1.8 mg/dL, SGPT < 2.5 x upper limit of normal
Cardiac function
Baseline left ventricular ejection fraction by ECHO or MUGA >= 50%
Serum biochemical values with the following limits unless considered due to leukemia, hemolysis or congenital disorder (creatinine < 1.8 mg/dl, total bilirubin < 1.8 mg/dL, [serum glutamate pyruvate transaminase (SGPT)] < 2.5 x upper limit of normal). White blood cell count < 25 x 10^9/L. Baseline left ventricular ejection fraction by echocardiogram (ECHO) or multigated acquisition (MUGA) >= 50%.
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 →
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