drugset / Trial / NCT04061421

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

NCT04061421

Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2021-11-24
Primary completion
2027-08
Completion
2027-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Itacitinib Small molecule Oral
Subject Ruxolitinib Small molecule 5 mg Oral
Subject Ruxolitinib Small molecule 15 mg Oral
Subject Ruxolitinib Small molecule 20 mg Oral
Background Cedazuridine Small molecule 100 mg Oral
Background Decitabine Small molecule 35 mg Oral