Back to search results

ABNL-MARRO Study for MDS/MPN Overlap Syndromes

This study, called ABNL-MARRO, is testing new combinations of medicines for people with Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN) overlap syndromes. It's looking at how safe and effective these combinations are. The current part of the study is testing ASTX727 (an oral drug combining decitabine and cedazuridine) along with ruxolitinib (a JAK1/JAK2 inhibitor). Another drug, Itacitinib, is also listed as an intervention. To join, you must be at least 18 years old and have a confirmed diagnosis of MDS/MPN. The study aims to see if these treatments lead to a good overall response, which includes complete, partial, or minor improvements in your condition. The overall response will be measured for up to 2 years.

Study design
This is an open-label, Phase 1/2 study, meaning you and your doctors will know which treatment you are receiving. It plans to enroll 94 participants.
What's involved
You would take ASTX727 by mouth daily for 5 days of every 28-day cycle. You would also take ruxolitinib by mouth twice a day for each 28-day cycle, with dosages of 5, 15, or 20mg. Itacitinib is also taken daily by mouth during each 28-day cycle.
Compensation
Not stated in the trial record.
Follow-up
The study will measure your overall response for up to 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04061421

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Michael Savona
~94 participants
Updated 2026-04-21 on ClinicalTrials.gov
What's tested:ASTX727ItacitinibRuxolitinib

At a glance

Recruiting sites
3 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 1: Determination of dose
Measured over Up to 28 days
+1 more outcome measured

Conditions

MDS/MPN

Explore related trials

Miller-Dieker Syndrome

NCT04061421

Where you'd take part

This study runs at 4 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Oregon Health Sciences University

    Portland, Oregonstudy coordinator listed

    Recruiting

  • University of Rochester Wilmot Cancer Institute

    Rochester, New Yorkstudy coordinator listed

    Recruiting

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennesseestudy coordinator listed

    Recruiting

  • Moffitt Cancer Center

    Tampa, Floridano site contact published

    Suspended

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Michael Savona, MD · STUDY_CHAIR · Vanderbilt-Ingram Cancer Center

Who to contact

Theradex Oncology US Inquiry
[email protected]
609.799.7580
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Patients treated with DNMTi therapy prior to enrollment in AM-001 who failed to achieve a complete remission, per the MDS/MPN IWG response criteria, after at least 4 cycles of DNMTi therapy
Patients enrolled in AM-001, or patients treated off-study with a regimen containing a DNMTi, who have definitive disease progression as defined in the protocol after at least 2 cycles of the prior therapy-this includes patients who fail to achieve a response with clearly progressive disease and patients who achieve an initial response who then lose that response;
Patients enrolled in AM-001 who have stable disease as best response at the second response evaluation after 6 cycles of the prior AM-001 therapy;
Patients treated on AM-001 who had and recovered from an adverse event that precludes further therapy on that Arm; after recovery from a toxicity that is likely to be related to ASTX727, enrollment in another AM-001 may occur provided that dose modifications are made as appropriate. 5. Must be willing to undergo bone marrow biopsy with aspiration during screening and bone marrow aspiration with tissue collection for disease assessment and correlative studies periodically throughout the trial. 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2. 7. Life expectancy of at least 3 months, as assessed by the treating physician. 8. For previously treated patients, recovery to ≤ Grade 1 or baseline of any toxicities due to prior systemic treatments, excluding alopecia. 9. Must have adequate hepatic and renal function during screening as demonstrated by:
ALT (SGPT) and AST (SGOT) ≤ 3x the institutional upper limit of normal (ULN);
Total bilirubin ≤ 1.5x ULN or ≤ 2x ULN, if upon judgment of the treating investigator the elevated bilirubin is due to extramedullary hematopoiesis related to the underlying MDS/MPN or to Gilbert's disease;
Calculated creatinine clearance (CrCl) ≥60 mL/min. For dose modification purposes in Arm B, CrCl should be calculated using the Cockcroft-Gault equation. For patients with renal impairment entering Arm B (ASTX727 + ruxolitinib), specific dose modifications per the section 6.5.4 will apply.

What this trial measures

  • Phase 1: Determination of doseUp to 28 days

    Per CTCAE 5.0

  • Phase 2: Overall response rate (ORR). Overall response includes patients who achieve best response of CR, PR, MR, or CB as defined by the MDS/MPN IWG proposed response criteriaUp to 2 years