RecruitingPhase 1Phase 2NCT04140487

Azacitidine, Venetoclax, and Gilteritinib in Treating Patients With Recurrent/Refractory FLT3-Mutated Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia, or High-Risk Myelodysplastic Syndrome/Myeloproliferative Neoplasm

A Phase I/II Study of Azacitidine, Venetoclax, and Gilteritinib for Patients With Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome With an Activating FLT3 Mutation


Sponsor

M.D. Anderson Cancer Center

Enrollment

97 participants

Start Date

Dec 17, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

This phase I/II trial studies the side effects and best dose of gilteritinib and to see how well it works in combination with azacitidine and venetoclax in treating patients with FLT3-mutation positive acute myeloid leukemia, chronic myelomonocytic leukemia, or high-risk myelodysplastic syndrome/myeloproliferative neoplasm that has come back (recurrent) or has not responded to treatment (refractory). Drugs used in chemotherapy, 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. Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Gilteritinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving azacitidine, venetoclax, and gilteritinib may work better compared to azacitidine and venetoclax alone in treating patients with acute myeloid leukemia, chronic myelomonocytic leukemia, or myelodysplastic syndrome/myeloproliferative neoplasm.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of three drugs — azacitidine, venetoclax, and gilteritinib — for people with certain types of blood cancer (acute myeloid leukemia or related conditions) that have a specific FLT3 gene mutation. The study includes newly diagnosed patients as well as those whose cancer has returned or not responded to prior treatment. **You may be eligible if...** - You are 18 or older - You have a diagnosis of AML (acute myeloid leukemia), CMML (chronic myelomonocytic leukemia), or high-risk myelodysplastic syndrome (MDS), with an FLT3 gene mutation - Depending on the study group (newly diagnosed vs. relapsed/refractory), you may or may not have had prior treatment - Your kidney, liver function, and heart rhythm (QTc) are within acceptable limits - You are able to swallow medications **You may NOT be eligible if...** - You have active central nervous system leukemia (cancer in the fluid around the brain) - You have HIV, active hepatitis B or C - You have serious heart failure (grade III-V) - You have a congenital long QT syndrome or severely abnormal heart rhythm - You are pregnant or breastfeeding - You have recently taken certain strong medications that interfere with this treatment 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

DRUGAzacitidine

Given IV

DRUGGilteritinib

Given PO

DRUGVenetoclax

Given PO


Locations(1)

M D Anderson Cancer Center

Houston, Texas, United States

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NCT04140487


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