Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT04493164 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial
NCT04493164 · ClinicalTrials.gov record · last posted 2026-08-25

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

StatusRecruiting
PhasePhase 2
Started2020-12-30
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
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.

Protocol amendment history 2 changes detected by DataLookout

2026-06-13
Primary completion pushed: 2026-06-01 → 2028-06-01
2026-06-13
Completion pushed: 2026-06-01 → 2028-06-01
Trial Details
NCT Number NCT04493164
Lead Sponsor M.D. Anderson Cancer Center
Conditions Acute Myeloid Leukemia With Gene Mutations, Myelodysplastic Syndrome, Myeloproliferative Neoplasm, Recurrent Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
Enrollment 30 participants
Start Date 2020-12-30
Primary Completion 2028-06-01 (estimated)
Study Completion 2028-06-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-25