A Phase 2/3, Multicenter, Randomized, Dose Optimization (Part I), Double-blind (Part II) Study to Compare the Efficacy and Safety of Oral Azacitidine (Oral-Aza, ONUREG®) Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Participants With IPSS-R Low- or Intermediate-risk Myelodysplastic Syndrome (MDS)

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT05469737Tipo: INTERVENTIONALInicio: 14 de dic de 2022Fin estimado: 31 de jul de 2028

Traducción no disponible, mostrando original

Resumen

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).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

• 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.

Criterios de exclusión

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

Intervenciones

drug

Oral Azacitidine

Specified dose on specified days

drug

Placebo for Oral Azacitidine

Specified dose on specified days

Ubicaciones

Local Institution - 0070

Pilar, Buenos Aires, Argentina

Local Institution - 0039

ABB, Buenos Aires F.D., Argentina

Local Institution - 0016

Buenos Aires, Argentina

Local Institution - 0022

Buenos Aires, Argentina

Local Institution - 0050

Buenos Aires, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

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