Active Myeloid Target Compound Combinations in MDS/MPN Overlap Syndromes Overlap Syndromes (ABNL-MARRO)

Conditions

• MDS/MPN

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• ASTX727 — DRUG
  Taken by mouth daily during days 1-5 of every 28-day cycle.
• Itacitinib — DRUG
  Taken by mouth daily during each 28-day cycle
• Ruxolitinib — DRUG
  Dosage will be 5,15, or 20mg Taken by mouth BID for 28-day cycle

Study Details

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.

Key Dates

Start date

Nov 24, 2021

Status verified

Feb 2026

Primary completion

Aug 31, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

94 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: ASTX727 + itacitinib
  ASTX727 and itacitinib will be taken by mouth
• Experimental: ASTX727 + ruxolitinib
  ASTX727 and ruxolitinib will be taken by mouth

Primary Outcome Measure

Phase 1: Determination of dose [ Time Frame: Up to 28 days ]

Central Contacts

• Theradex Oncology US Inquiry
  609.799.7580
  [email protected]
• Theradex Oncology EU Inquiry
  +44 (0)1293 510 319
  [email protected]

Locations (4)

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