RecruitingPhase 1Phase 2NCT04493138

Azacitidine and Quizartinib for the Treatment of Myelodysplastic Syndrome or Myelodysplastic/Myeloproliferative Neoplasm With FLT3 or CBL Mutations

Phase I/II Study of Azacitidine in Combination With Quizartinib for Patients With Myelodysplastic Syndromes and Myelodysplastic/Myeloproliferative Neoplasms With FLT3 or CBL Mutations

Sponsor

M.D. Anderson Cancer Center

Enrollment

58 participants

Start Date

Jul 21, 2020

Study Type

INTERVENTIONAL

Conditions

Myelodysplastic Syndrome Recurrent Chronic Myelomonocytic Leukemia Recurrent Myelodysplastic Syndrome Chronic Myelomonocytic Leukemia Myeloproliferative Neoplasm Recurrent Myeloproliferative Neoplasm

Summary

This phase I/II trial studies the side effects and best dose of quizartinib when given with azacitidine and to see how well they work in treating patients with myelodysplastic syndrome or myelodysplastic/myeloproliferative neoplasm with FLT3 or CBL mutations. Chemotherapy drugs, 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. Quizartinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving azacitidine and quizartinib may help to control myelodysplastic syndrome or myelodysplastic/myeloproliferative neoplasm.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of azacitidine (a drug that can turn cancer-suppressing genes back on) and quizartinib (a targeted drug that blocks a growth signal called FLT3) for patients with myelodysplastic syndrome (MDS) or a related blood disorder with FLT3 or CBL gene mutations. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of MDS or a related bone marrow condition (MDS/MPN) - Your disease is high-risk or has not responded to prior treatment with similar drugs (hypomethylating agents) - Your cancer has a FLT3 or CBL mutation identified on genetic testing **You may NOT be eligible if...** - You have not had the required genetic testing - You have already received quizartinib - You have serious heart problems (especially QTc prolongation) - 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

DRUGAzacitidine

Given SC or IV

DRUGQuizartinib

Given PO

Locations(1)

M D Anderson Cancer Center

Houston, Texas, United States

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NCT04493138

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