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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)
Sponsor: National Cancer Institute (NCI)
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 59 Years
Study Type
INTERVENTIONAL
Enrollment
122
Start Date
2027-01-15
Completion Date
2027-12-31
Last Updated
2026-10-07
Healthy Volunteers
No
Conditions
Interventions
Azacitidine
Given IV or SC
Biospecimen Collection
Undergo blood sample collection
Bone Marrow Aspiration
Undergo bone marrow aspiration
Bone Marrow Biopsy
Undergo bone marrow biopsy
Cytarabine
Given IV
Daunorubicin
Given IV
Echocardiography Test
Undergo echocardiography
Multigated Acquisition Scan
Undergo MUGA scan
Quizartinib
Given PO
Venetoclax
Given PO