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

NCT04493164 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-05-22

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

Liposome-encapsulated Daunorubicin-Cytarabine

Given IV

DRUG

Ivosidenib

Given PO

Sponsors & Collaborators

M.D. Anderson Cancer Center
lead OTHER

Principal Investigators

Courtney DiNardo, MD · M.D. Anderson Cancer Center

Study Design

Allocation: NA
Purpose: TREATMENT
Masking: NONE
Model: SINGLE_GROUP

Eligibility

Min Age: 18 Years
Sex: ALL
Healthy Volunteers: No

Timeline & Regulatory

Start: 2020-12-30
Primary Completion: 2026-06-01
Completion: 2026-06-01
FDA Drug: Yes

Countries

United States

Study Locations

More Related Trials

Entities

Diseases

Myelodysplastic Syndrome