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  • NCT06045689

Recruiting

A Study to Assess Luspatercept in Lower-risk Myelodysplastic Syndrome Participants - CA056-1060

Oppdatert: 3 mai, 2024   |   ClinicalTrials.gov

Utskriftsvennlig Sammendrag

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  • Phase 3

    Fase

  • Kjønn

  • 18+

    Aldersgruppe

  • 52

    Sted(er)

  • Recruiting

Behandlingsalternativer

Studiearmer
TILDELT INTERVENSJON
Experimental: Cohort 1: erythropoiesis-stimulating agents (ESA) naïve
Drug: Luspatercept
Experimental: Cohort 2: ESA relapsed or refractory
Drug: Luspatercept

Nøkkelkriterier for kvalifikasjon

Inclusion Criteria: - Participant had documented diagnosis of MDS according to World Health Organization (WHO) classification that met Revised International Prognostic Scoring System (IPSS-R) classification of very low-, low-, or intermediate-risk disease. - Participant has an Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2. - Participant must have red blood cell transfusions according to study criteria. Exclusion Criteria: - Participant has known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or gastrointestinal bleeding. - Participant has had a prior allogeneic or autologous stem cell transplant. - Participant has known history or diagnosis of AML. - Participant has uncontrolled hypertension. Other protocol-defined inclusion/exclusion criteria apply

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MLTNO2000046