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

NCT04061421 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2026-04-21

No results posted yet for this 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

  • MDS/MPN

Interventions

DRUG

ASTX727

Taken by mouth daily during days 1-5 of every 28-day cycle.

DRUG

Itacitinib

Taken by mouth daily during each 28-day cycle

DRUG

Ruxolitinib

Dosage will be 5,15, or 20mg Taken by mouth BID for 28-day cycle

Sponsors & Collaborators

  • Incyte Corporation

    collaborator INDUSTRY

  • Theradex

    collaborator INDUSTRY

  • Astex Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Michael Savona

    lead OTHER

Principal Investigators

  • Michael Savona, MD · Vanderbilt-Ingram Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-24
Primary Completion
2027-08-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04061421 on ClinicalTrials.gov