OncoMatch/Clinical Trials/NCT04493138
Azacitidine and Quizartinib for the Treatment of Myelodysplastic Syndrome or Myelodysplastic/Myeloproliferative Neoplasm With FLT3 or CBL Mutations
Is NCT04493138 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Azacitidine and Quizartinib for chronic myelomonocytic leukemia.
Treatment: Azacitidine · Quizartinib — This phase I/II trial studies the side effects and best dose of quizartinib when given with azacitidine and to see how well they work in treating patients with myelodysplastic syndrome or myelodysplastic/myeloproliferative neoplasm with FLT3 or CBL mutations. Chemotherapy drugs, such as azacitidine, 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. Quizartinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving azacitidine and quizartinib may help to control myelodysplastic syndrome or myelodysplastic/myeloproliferative neoplasm.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Myeloproliferative Neoplasm
Biomarker criteria
Required: FLT3 ITD
Detectable FLT3-ITD mutation in bone marrow and/or peripheral blood
Required: CBL exon 8 deletion
presence of CBL exon 8 or 9 deletions or point mutations
Required: CBL exon 9 deletion
presence of CBL exon 8 or 9 deletions or point mutations
Required: CBL exon 8 point mutation
presence of CBL exon 8 or 9 deletions or point mutations
Required: CBL exon 9 point mutation
presence of CBL exon 8 or 9 deletions or point mutations
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: hypomethylating agent (azacitidine, decitabine, guadecitabine, ASTX727)
no response after 6 cycles of azacitidine, decitabine, guadecitabine or ASTX727 or relapse or progression after any number of cycles
Lab requirements
Kidney function
Serum creatinine ≤2xULN
Liver function
total bilirubin <2x ULN (will allow <5xULN if Gilbert's at investigator's discretion), AST or ALT ≤3xULN
Cardiac function
QTcF ≤450 msec; no congenital long QT syndrome; no sustained ventricular tachycardia requiring intervention; no history of ventricular fibrillation or torsades de pointes; no second- or third-degree heart block (unless pacemaker); sustained HR ≥50/min; no bifascicular block (RBBB + LAHB); no complete LBBB; no atrial fibrillation within 2 weeks; NYHA Class I-II CHF only; LVEF ≥50%; no MI within 6 months; no unstable angina; no severe/uncontrolled ventricular arrhythmias
Serum creatinine ≤2xULN. Adequate hepatic function with total bilirubin <2x ULN (will allow <5xULN if Gilbert's at investigator's discretion), AST or ALT ≤3xULN. Cardiac exclusion criteria as listed.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- M D Anderson Cancer Center · Houston, Texas
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