RecruitingPhase 2NCT04493164

CPX-351 and Ivosidenib for the Treatment of IDH1 Mutated Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome

Phase II Investigator Sponsored Study of CPX-351 in Combination With Ivosidenib for Patients With IDH1 Mutated Acute Myeloid Leukemia or High-Risk MDS

Sponsor

M.D. Anderson Cancer Center

Enrollment

30 participants

Start Date

Dec 30, 2020

Study Type

INTERVENTIONAL

Conditions

Myelodysplastic Syndrome Myeloproliferative Neoplasm Recurrent Acute Myeloid Leukemia Refractory Acute Myeloid Leukemia Acute Myeloid Leukemia With Gene Mutations

Summary

This phase II trial investigates how well CPX-351 and ivosidenib work in treating patients with acute myeloid leukemia or high-risk myelodysplastic syndrome that has IDH1 mutation. The safety of this drug combination will also be studied. IDH1 is a type of genetic mutation (change). Chemotherapy drugs, such as CPX-351, 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. Ivosidenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. The purpose of this trial is to learn if CPX-351 in combination with ivosidenib can help to control IDH1-mutated acute myeloid leukemia or high-risk myelodysplastic syndrome.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of CPX-351 (a chemotherapy drug) and ivosidenib (a targeted drug) for patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS) that has a specific genetic mutation called IDH1. This mutation causes abnormal cell growth that ivosidenib is designed to block. **You may be eligible if...** - You have AML or high-risk MDS with a confirmed IDH1 mutation (specifically the R132 variant) - You are newly diagnosed or your disease has relapsed or is refractory - You are eligible for intensive chemotherapy - Your liver and kidney function meet minimum requirements **You may NOT be eligible if...** - You do not have an IDH1 mutation - You are unable to tolerate intensive chemotherapy - You have significant QT interval prolongation on ECG - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIvosidenib

Given PO

DRUGLiposome-encapsulated Daunorubicin-Cytarabine

Given IV

Locations(1)

M D Anderson Cancer Center

Houston, Texas, United States

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NCT04493164

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