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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: Recruiting Phase 2 study of Myelodysplastic Syndrome, sponsored by National Cancer Institute (NCI).
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Will be assessed using the International Working Group 2023 (IWG2023) criteria. Will compare the CR rate between the two treatment arms to determine if patients treated with enasidenib + ASTX727 have a statistically significantly higher CR rate than patients treated with the ASTX727 monotherapy.
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 |
What NCT06577441 shows while recruiting
NCT06577441 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 207-participant average among 134 other Myelodysplastic Syndrome trials with a reported enrollment target (74% lower).
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 names 20 study sites across 5 states, led by 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.
Learn More About Clinical Trials
Similar trials for Myelodysplastic Syndrome
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06577441's enrollment target sits among peer trials
54 60th of 134 higher than 71 of 134 other Myelodysplastic Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Myelodysplastic Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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