OncoMatch/Clinical Trials/NCT04493164
CPX-351 and Ivosidenib for the Treatment of IDH1 Mutated Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
Is NCT04493164 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Ivosidenib and Liposome-encapsulated Daunorubicin-Cytarabine for acute myeloid leukemia with gene mutations.
Treatment: Ivosidenib · Liposome-encapsulated Daunorubicin-Cytarabine — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Myeloproliferative Neoplasm
Biomarker criteria
Required: IDH1 R132
IDH1-R132 mutated disease status as assessed by local laboratory
Allowed: IDH1 R100
2HG-producing IDH1 variants outside of R132 (i.e. R100) may be eligible after discussion with the principal investigator (PI)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: cpx-351 (cpx-351)
Lab requirements
Kidney function
creatinine clearance ≥ 30 ml/min based on the Cockcroft-Gault equation
Liver function
direct bilirubin ≤ 2 x ULN, ALT and/or AST ≤ 3 x ULN unless deemed to be related to underlying leukemia
Cardiac function
No symptomatic congestive heart failure (NYHA Class III or IV), unstable angina, or an ejection fraction < 45%
Adequate hepatic function (direct bilirubin ≤ 2 x ULN, ALT and/or AST ≤ 3 x ULN unless deemed to be related to underlying leukemia). Adequate renal function including creatinine clearance ≥ 30 ml/min based on the Cockcroft-Gault equation. Patients with symptomatic congestive heart failure (NYHA Class III or IV), unstable angina, or an ejection fraction < 45% [excluded].
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- M D Anderson Cancer Center · Houston, Texas
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