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NCT04061421 · ClinicalTrials.gov registry record · Phase 1
Active Myeloid Target Compound Combinations in MDS/MPN Overlap Syndromes Overlap Syndromes (ABNL-MARRO)
A Phase 1 study of MDS/MPN, sponsored by Michael Savona.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 94
- Enrollment target
- 4
- Study locations
NCT04061421 is a Phase 1 study of MDS/MPN that is actively recruiting participants, run by Michael Savona. The registered enrollment target is 94 participants. The trial reports 4 study locations across 4 states.
The verdict
NCT04061421, a Phase 1 study of MDS/MPN, is actively recruiting participants, sponsored by Michael Savona.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 94 participants
- Enrollment target
- 4
- Study locations
Study Summary
ABNL-MARRO (A Basket study of Novel therapy for untreated MDS/MPN and Relapsed/Refractory Overlap Syndromes) is an international European-American cooperation providing the framework for collaborative studies to advance treatment of myelodysplastic/myeloproliferative neoplasms (MDS/MPN) and explore clinical-pathologic markers of disease severity, prognosis and treatment response. ABNL MARRO 001 (AM-001) is an Open label, phase 1/2 study within the framework of the ABNL-MARRO that will test novel treatment combinations in MDS/MPN. Each Arm of AM-001 will test an active myeloid target compound in combination with ASTX727, an oral drug combining fixed doses of the DNA methyltransferase inhibitor (DNMTi) decitabine and the cytidine deaminase inhibitor E7727, also known as cedazuridine in a single tablet.
Conditions Studied
Interventions
- DRUG Ruxolitinib
- DRUG ASTX727
- DRUG Itacitinib
Study Locations (4)
Florida
- Moffitt Cancer Center - Tampa
New York
- University of Rochester Wilmot Cancer Institute - Rochester
Oregon
- Oregon Health Sciences University - Portland
Tennessee
- Vanderbilt-Ingram Cancer Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 94 participants |
| Start Date | 2021-11-24 |
| Est. Completion | 2027-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04061421
The ClinicalTrials.gov registry entry for NCT04061421 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 94 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Michael Savona, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with MDS/MPN appearing as the primary indexed condition, and to 3 interventions - of which Ruxolitinib is the first listed.
NCT04061421 reports 4 study locations spanning 4 distinct geographic areas - top geographies include Florida, New York, Oregon.
Frequently Asked Questions
What is clinical trial NCT04061421 about?
NCT04061421 is a clinical study titled "Active Myeloid Target Compound Combinations in MDS/MPN Overlap Syndromes Overlap Syndromes (ABNL-MARRO)". ABNL-MARRO (A Basket study of Novel therapy for untreated MDS/MPN and Relapsed/Refractory Overlap Syndromes) is an international European-American cooperation providing the framework for collaborative studies to advance treatment of myelodysplastic/myeloproliferative neoplasms (MDS/MPN) and explore ...
What is the current status of trial NCT04061421?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 94 participants. The study started on 2021-11-24. Estimated completion is 2027-12.
What conditions does trial NCT04061421 study?
This clinical trial studies the following conditions: MDS/MPN.
What interventions are being tested in trial NCT04061421?
The interventions under investigation include: Ruxolitinib (DRUG), ASTX727 (DRUG), Itacitinib (DRUG).
Who is sponsoring clinical trial NCT04061421?
This trial is sponsored by Michael Savona, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04061421 being conducted?
This trial has 4 study locations across Florida, New York, Oregon, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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