RecruitingPhase 1Phase 2NCT03661307

Quizartinib, Decitabine, and Venetoclax in Treating Participants With Untreated or Relapsed Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome

A Phase I/II Study of Quizartinib in Combination With Decitabine and Venetoclax for the Treatment of Patients With Acute Myeloid Leukemia (AML)


Sponsor

M.D. Anderson Cancer Center

Enrollment

73 participants

Start Date

Oct 31, 2018

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a three-drug combination — quizartinib, decitabine, and venetoclax — for people with a type of blood cancer called acute myeloid leukemia (AML) or a high-risk form of a bone marrow disorder called myelodysplastic syndrome (MDS), either newly diagnosed or returned after prior treatment. **You may be eligible if...** - You have been diagnosed with AML (with 20% or more abnormal blood cells in the marrow) or high-risk MDS (more than 10% abnormal cells) - For newly diagnosed patients: you are not a candidate for standard chemotherapy, or you have AML with a specific genetic mutation (FLT3) - For relapsed/refractory patients: your cancer came back or did not respond to prior treatment - You are in adequate overall health with acceptable blood and organ function **You may NOT be eligible if...** - You have a subtype called acute promyelocytic leukemia (APL) - You have active heart rhythm problems (such as a prolonged QT interval) or are on medications that affect heart rhythm - You have active infection or severe organ dysfunction - You are pregnant or breastfeeding 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

DRUGDecitabine

Given IV

DRUGQuizartinib

Given PO

DRUGVenetoclax

Given PO


Locations(1)

M D Anderson Cancer Center

Houston, Texas, United States

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NCT03661307


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