RecruitingPhase 1Phase 2NCT04128748

Liposomal Cytarabine and Daunorubicin (CPX-351) and Quizartinib for the Treatment of Acute Myeloid Leukemia and High Risk Myelodysplastic Syndrome

A Phase I/II Study of Liposomal Cytarabine and Daunorubicin (CPX-351) in Combination With Quizartinib in Patients With Acute Myeloid Leukemia (AML) and High Risk Myelodysplastic Syndrome (MDS)


Sponsor

M.D. Anderson Cancer Center

Enrollment

52 participants

Start Date

May 27, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

This phase I/II trial studies the side effects and best dose of CPX-351 in combination with quizartinib for the treatment of acute myeloid leukemia and high risk myelodysplastic syndrome. CPX-351, composed of chemotherapy drugs daunorubicin and cytarabine, works 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 tumor cells by blocking some of the enzymes needed for cell growth. The goal of this study is to learn if the combination of CPX-351 and quizartinib can help to control acute myeloid leukemia and myelodysplastic syndrome.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two cancer drugs — CPX-351 (a type of chemotherapy) and quizartinib — for people with a specific type of blood cancer called acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS), particularly those with a FLT3 gene mutation. **You may be eligible if...** - You have been diagnosed with AML or high-risk MDS - If newly diagnosed: you are 60 or older and have not had prior chemotherapy for this cancer - If relapsed or returned: you are 18 or older and have received at least one prior treatment - Your heart, liver, and kidney function are within acceptable levels - You are able to swallow oral medications **You may NOT be eligible if...** - You have a known allergy to quizartinib or CPX-351 - You have serious heart problems (abnormal heart rhythm, heart failure, recent heart attack) - You have a congenital long QT syndrome (a heart electrical condition) - You have HIV, active hepatitis B or C - You have recently eaten grapefruit or Seville oranges (within 3 days) - You are pregnant or planning to become pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLiposome-encapsulated Daunorubicin-Cytarabine

Given IV

DRUGQuizartinib

Given PO


Locations(1)

M D Anderson Cancer Center

Houston, Texas, United States

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NCT04128748


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