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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: Recruiting Phase 1 study of MDS/MPN, sponsored by Michael Savona.
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, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% higher). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Per CTCAE 5.0
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 |
What NCT04061421 shows while recruiting
NCT04061421 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 94 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% higher).
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 a single indexed study location in 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04061421's enrollment target sits among peer trials
94 616th of 2000 higher than 1,377 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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