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Trial ID CA055-026  |   NCT05469737

A Study to Compare the Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Participants With International Prognostic Scoring System Revised (IPSS-R) Low- or Intermediate-risk Myelodysplastic Syndrome (MDS)

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Summary

  • Phase 2/Phase 3
  • Male and Female Gender icon
  • 18+
    Age Range
  • BMS Active Not Yet Recruiting Study icon
    Active, Not Recruiting

Overview

The purpose of this study is to evaluate the safety and efficacy of oral azacitidine in participants with low to intermediate International Prognostic Scoring System Revised (IPSS-R) myelodysplastic syndrome (MDS).

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Key Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Icon img
: • Participant has a documented diagnosis of MDS according to WHO 2016 classification that meets International Prognostic Scoring System Revised (IPSS-R) classification of low
  • or intermediate-risk disease (IPSS-R score between 1.5 and 4.5). MDS diagnosis, WHO classification, and IPSS-R risk classification will be prospectively determined by independent central pathology and cytogenetics review, and applicable central laboratory results. • Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.

    Exclusion Criteria

    Exclusion Criteria Icon
    :
    • Participants with prior malignancies must have an expected median life expectancy of at least 12 months at the time of inclusion and no active treatment of any sort for at least 24 weeks prior to randomization (including but not limited to immunotherapy or targeted therapy)
      1. Hypoplastic Myelodysplastic Syndrome (MDS) with a marrow cellularity of ≤ 10%
        1. Participants diagnosed with MDS with excess blasts-2 (MDS-EB2)
          1. Prior treatment with azacitidine (any formulation), decitabine, or other hypomethylating agent Other protocol-defined inclusion/exclusion criteria apply
            Additional Information *

            Treatment Options

            Study Arms

            ASSIGNED INTERVENTION

            Study Arms

            Experimental: Part I - Oral-Aza (Dose 1)

            ASSIGNED INTERVENTION
            • Drug: Oral Azacitidine

            Study Arms

            Experimental: Part I - Oral-Aza (Dose 2)

            ASSIGNED INTERVENTION
            • Drug: Oral Azacitidine

            Study Arms

            Experimental: Part II - Oral-Aza (RP3D)

            ASSIGNED INTERVENTION
            • Drug: Oral Azacitidine

            Study Arms

            Experimental: Part II - Placebo

            ASSIGNED INTERVENTION
            • Drug: Placebo for Oral Azacitidine

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