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NCT06577441 · ClinicalTrials.gov registry record · Phase 2
Testing the Addition of an IDH2 Inhibitor, Enasidenib, to Usual Treatment (Cedazuridine-Decitabine) for Higher-Risk Myelodysplastic Syndrome (MDS) With IDH2 Mutation (A MyeloMATCH Treatment Trial)
A Phase 2 study of Myelodysplastic Syndrome, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 54
- Enrollment target
- 20
- Study locations
NCT06577441 is a Phase 2 study of Myelodysplastic Syndrome that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 54 participants, below the 207-participant average among 134 other Myelodysplastic Syndrome trials with a reported enrollment target (74% lower). The trial reports 20 study locations across 5 states.
The verdict
NCT06577441, a Phase 2 study of Myelodysplastic Syndrome, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 54 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II MyeloMATCH treatment trial compares the usual treatment of cedazuridine-decitabine (ASTX727) to the combination treatment of ASTX727 and enasidenib in treating patients with higher-risk, IDH2-mutated myelodysplastic syndrome (MDS). ASTX727 is a combination of two drugs, decitabine and cedazuridine. Cedazuridine is in a class of medications called cytidine deaminase inhibitors. It prevents the breakdown of decitabine, making it more available in the body so that decitabine will have a greater effect. Decitabine is in a class of medications called hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. Enasidenib is an enzyme inhibitor that may stop the growth of cells by blocking some of the enzymes needed for cell growth. Giving ASTX727 in combination with enasidenib may be effective in treating patients with higher-risk IDH2-mutated MDS.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Bone Marrow Aspiration
- PROCEDURE Bone Marrow Biopsy
- DRUG Decitabine and Cedazuridine
- DRUG Enasidenib
Study Locations (20)
Idaho
- Saint Luke's Cancer Institute - Boise - Boise
- Kootenai Health - Coeur d'Alene - Coeur d'Alene
- Saint Luke's Cancer Institute - Fruitland - Fruitland
- Saint Luke's Cancer Institute - Meridian - Meridian
- Saint Alphonsus Cancer Care Center-Nampa - Nampa
- Saint Luke's Cancer Institute - Nampa - Nampa
- Kootenai Clinic Cancer Services - Post Falls - Post Falls
- Kootenai Clinic Cancer Services - Sandpoint - Sandpoint
Illinois
- Illinois CancerCare-Bloomington - Bloomington
- Illinois CancerCare-Canton - Canton
- Illinois CancerCare-Carthage - Carthage
- Northwestern University - Chicago
- Swedish Covenant Hospital - Chicago
California
- Alta Bates Summit Medical Center-Herrick Campus - Berkeley
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care - Irvine
- UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange
- Mills Health Center - San Mateo
Florida
- Miami Cancer Institute - Miami
- Memorial Hospital West - Pembroke Pines
Georgia
- Phoebe Putney Memorial Hospital - Albany
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2025-06-12 |
| Est. Completion | 2027-03-01 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06577441
The ClinicalTrials.gov registry entry for NCT06577441 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 54 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 (74% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Myelodysplastic Syndrome appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT06577441 reports 20 study locations spanning 5 distinct geographic areas - top geographies include Idaho, Illinois, California.
Frequently Asked Questions
What is clinical trial NCT06577441 about?
NCT06577441 is a clinical study titled "Testing the Addition of an IDH2 Inhibitor, Enasidenib, to Usual Treatment (Cedazuridine-Decitabine) for Higher-Risk Myelodysplastic Syndrome (MDS) With IDH2 Mutation (A MyeloMATCH Treatment Trial)". This phase II MyeloMATCH treatment trial compares the usual treatment of cedazuridine-decitabine (ASTX727) to the combination treatment of ASTX727 and enasidenib in treating patients with higher-risk, IDH2-mutated myelodysplastic syndrome (MDS). ASTX727 is a combination of two drugs, decitabine and ...
What is the current status of trial NCT06577441?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 54 participants. The study started on 2025-06-12. Estimated completion is 2027-03-01.
What conditions does trial NCT06577441 study?
This clinical trial studies the following conditions: Myelodysplastic Syndrome.
What interventions are being tested in trial NCT06577441?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Bone Marrow Aspiration (PROCEDURE), Bone Marrow Biopsy (PROCEDURE), Decitabine and Cedazuridine (DRUG), Enasidenib (DRUG).
Who is sponsoring clinical trial NCT06577441?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06577441 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Idaho, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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