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RECRUITING 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)

NCT06577441 · View on ClinicalTrials.gov ↗

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

FieldValue
Enrollment Target 54 participants
Start Date 2025-06-12
Est. Completion 2027-03-01
Phase Phase 2

Sponsor

National Cancer Institute (NCI)

2,390 total trials

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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06577441 reports 20 study locations spanning 5 distinct geographic areas — top geographies include Idaho, Illinois, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06577441?

This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial