Actively Recruiting
Active Myeloid Target Compound Combinations in MDS/MPN Overlap Syndromes Overlap Syndromes (ABNL-MARRO)
Led by Michael Savona · Updated on 2026-04-21
94
Participants Needed
4
Research Sites
314 weeks
Total Duration
On this page
Sponsors
M
Michael Savona
Lead Sponsor
I
Incyte Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Active Myeloid Target Compound Combinations in MDS/MPN Overlap Syndromes Overlap Syndromes (ABNL-MARRO)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must be 18 years of age or older and able to give informed consent
- Confirmed diagnosis of MDS/MPN (excluding JMML) by WHO 2016 criteria
- Treatment-nafve patients may enroll in any open arm in phase 1 or 2
- Patients who failed or were intolerant to prior DNMTi therapy may enroll in certain arms after wash-out
- Willing to undergo bone marrow biopsy and aspiration during screening and periodically
- Eastern Cooperative Oncology Group (ECOG) status of 0, 1, or 2
- Life expectancy of at least 3 months as assessed by physician
- Recovery to Grade 1 or baseline of toxicities from prior treatments (excluding hair loss)
- Adequate liver and kidney function with specific lab value limits
You will not qualify if you...
- Prior exposure to novel targeted agents itacitinib or ruxolitinib; prior ASTX727 exposure allowed if other criteria met
- Use of investigational drugs within 30 days or 5 half-lives before study start, unless approved
- Systemic chemotherapy including DNMTi within 21 days or 5 half-lives before study start
- Known allergy to decitabine or ruxolitinib
- Transformation to acute myeloid leukemia (>20% blasts in marrow or blood)
- Organ transplant recipients including stem cell transplant
- Significant uncontrolled heart disease or recent serious cardiac events
- Thromboembolic events within 6 months before study
- Active hepatitis B or C infection; HIV positive status
- Abnormal ECG deemed clinically significant or QTc >500 ms (with exceptions)
- Contraindications to ASTX727 use
- Active significant bleeding
- Other active cancers except certain localized or controlled cancers
- Recent wide-field radiotherapy or unresolved side effects from radiation
- Need for prohibited medications without alternatives
- Active uncontrolled infection
- Major surgery within 4 weeks prior to treatment (except central line placement)
- Pregnant or breastfeeding women
- Expectation to conceive or father children during study without effective contraception
- Serious unstable medical or psychiatric conditions affecting compliance
- Psychological, familial, geographic, or social conditions affecting compliance
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Trial Site Locations
Total: 4 locations
1
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Suspended
2
University of Rochester Wilmot Cancer Institute
Rochester, New York, United States, 14609
Actively Recruiting
3
Oregon Health Sciences University
Portland, Oregon, United States, 97239
Actively Recruiting
4
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
Research Team
T
Theradex Oncology US Inquiry
CONTACT
T
Theradex Oncology EU Inquiry
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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