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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) - CA055-026

Actualizada: 1 agosto, 2022   |   ClinicalTrials.gov

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Detalles del estudio

  • Phase 2/Phase 3

    Fase

  • Géneros

  • 18+

    Rango de edad

  • 2

    Ubicación (es)

  • Not Yet Recruiting

Opciones de tratamiento

Brazos del estudio
INTERVENCIÓN ASIGNADA
Experimental: Part I - Oral-Aza (Dose 1)
Drug: Oral Azacitidine
Experimental: Part I - Oral-Aza (Dose 2)
Drug: Oral Azacitidine
Experimental: Part II - Oral-Aza (RP3D)
Drug: Oral Azacitidine
Experimental: Part II - Placebo
Drug: Placebo for Oral Azacitidine

Criterios clave de elegibilidad

Inclusion Criteria: - Participant has a documented diagnosis of MDS according to WHO 2016 classification that meets International Prognostic Scoring System Revised (IPSS-R) classification 17 of low- or intermediate-risk disease (IPSS-R score between 1.5 and 4.5) - Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. Exclusion Criteria: - 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) - Hypoplastic Myelodysplastic Syndrome (MDS) with a marrow cellularity of ≤ 10% - Participants diagnosed with MDS with excess blasts-2 (MDS-EB2) - Prior treatment with azacitidine (any formulation), decitabine, or other hypomethylating agent Other protocol-defined inclusion/exclusion criteria apply

Recomendamos encarecidamente que se comunique con BMS para informar los efectos secundarios (eventos adversos)
Los efectos secundarios (eventos adversos) y otros eventos reportables se definen aquí
Informe de efectos secundarios (eventos adversos) o quejas sobre la calidad del producto: información médica

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¿Tiene alguna pregunta? El soporte en vivo está disponible 24/7 -
Llame 855-907-3286 o Envíenos un correo electrónico