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NCT04493164 · ClinicalTrials.gov registry record · Phase 2
CPX-351 and Ivosidenib for the Treatment of IDH1 Mutated Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
A Phase 2 study of Myelodysplastic Syndrome and Refractory Acute Myeloid Leukemia, sponsored by M.D. Anderson Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT04493164 is a Phase 2 study of Myelodysplastic Syndrome and Refractory Acute Myeloid Leukemia that is actively recruiting participants, run by M.D. Anderson Cancer Center. The registered enrollment target is 30 participants, below the 207-participant average among 134 other Myelodysplastic Syndrome trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04493164, a Phase 2 study of Myelodysplastic Syndrome and Refractory Acute Myeloid Leukemia, is actively recruiting participants, sponsored by M.D. Anderson Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
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 Studied
Interventions
- DRUG Liposome-encapsulated Daunorubicin-Cytarabine
- DRUG Ivosidenib
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2020-12-30 |
| Est. Completion | 2026-06-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04493164
The ClinicalTrials.gov registry entry for NCT04493164 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 207-participant average among 134 other Myelodysplastic Syndrome trials with a reported enrollment target (86% lower). The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Myelodysplastic Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Liposome-encapsulated Daunorubicin-Cytarabine is the first listed.
NCT04493164 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT04493164 about?
NCT04493164 is a clinical study titled "CPX-351 and Ivosidenib for the Treatment of IDH1 Mutated Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome". 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 dru...
What is the current status of trial NCT04493164?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2020-12-30. Estimated completion is 2026-06-01.
What conditions does trial NCT04493164 study?
This clinical trial studies the following conditions: Myelodysplastic Syndrome, Refractory Acute Myeloid Leukemia, Recurrent Acute Myeloid Leukemia, Myeloproliferative Neoplasm, Acute Myeloid Leukemia With Gene Mutations.
What interventions are being tested in trial NCT04493164?
The interventions under investigation include: Liposome-encapsulated Daunorubicin-Cytarabine (DRUG), Ivosidenib (DRUG).
Who is sponsoring clinical trial NCT04493164?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04493164 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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