At a glance
ClinicalIndex Comparison Record- ✓ECOG performance status 0-2
- ✓IDH1-R132 mutated disease confirmed by local lab
- ✓Treatment naive or relapsed/refractory AML eligible for intensive chemotherapy
- ✓High-risk MDS (IPSS-R ≥4) or MPN (D-IPSS ≥3) may be eligible with PI discussion
- ✕Prior CPX-351 therapy
- ✕Uncontrolled clinically significant medical condition including infection, lab abnormality, or psychiatric illness
- ✕Other chemotherapeutic or anti-leukemic agents during study (except intrathecal prophylaxis, controlled CNS leukemia, hydroxyurea, or limited cytarabine ≤2 g/m²)
- ✕Active GVHD post-stem cell transplant (stable/no active GVHD on chronic suppression permitted with PI discussion)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Investigator Sponsored Study of CPX-351 in Combination With Ivosidenib for Patients With IDH1 Mutated Acute Myeloid Leukemia or High-Risk MDS
In Brief
A Phase 2 clinical trial evaluating Ivosidenib and Liposome-encapsulated Daunorubicin-Cytarabine for Acute Myeloid Leukemia With Gene Mutations and 4 related conditions. Currently recruiting, targeting 30 participants across 1 site.
Detailed 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.
Study Details
Timeline
Arms & Interventions
INDUCTION: Patients receive CPX-351 IV over 90 minutes on days 1, 3, and 5, and ivosidenib PO QD on days 1-28. Patients who do not achieve complete remission may receive a second cycle of induction therapy in the absence of disease progression or unacceptable toxicity. Patients achieving complete remission proceed to consolidation. CONSOLIDATION: Patients receive CPX-351 IV over 90 minutes on days 1 and 3, and ivosidenib PO QD on days 1-28. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive ivosidenib PO QD for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients who are experiencing clinical benefit and who have not experienced excessive toxicity after completion of 2 years of maintenance may be eligible to continue therapy after discussion with the principal investigator.
Interventions
Given PO
Given IV