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NOT YET RECRUITING
NCT07862517
PHASE2

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)

View on ClinicalTrials.gov

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

Interventions

DRUG

Azacitidine

Given IV or SC

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Bone Marrow Aspiration

Undergo bone marrow aspiration

PROCEDURE

Bone Marrow Biopsy

Undergo bone marrow biopsy

DRUG

Cytarabine

Given IV

DRUG

Daunorubicin

Given IV

PROCEDURE

Echocardiography Test

Undergo echocardiography

PROCEDURE

Multigated Acquisition Scan

Undergo MUGA scan

DRUG

Quizartinib

Given PO

DRUG

Venetoclax

Given PO