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Recruiting

Registro de enfermedades mieloides Connect® - AZA-MDS-006

Actualizada: 30 abril, 2024   |   ClinicalTrials.gov

Celgene es una filial íntegramente participada por Bristol-Myers Squibb Company

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Detalles del estudio

  • Géneros

  • 18+

    Rango de edad

  • 90

    Ubicaciones

  • Recruiting

Opciones de tratamiento

Brazos del estudio
INTERVENCIÓN ASIGNADA
Citopenia idiopática de significado incierto (Idiopathic cytopenia of undetermined significance, ICUS) de diagnóstico reciente
Cohorte tratada con luspatercept (LTC)
Fármaco: Luspatercept
Leucemia mieloide aguda (LMA) de diagnóstico reciente
Mielofibrosis (MF) tratada
Síndrome mielodisplásico (SMD) de alto riesgo de diagnóstico reciente
Síndrome mielodisplásico (SMD) de bajo riesgo de diagnóstico reciente
Síndrome mielodisplásico (SMD) de bajo riesgo tratado

Criterios clave de elegibilidad

Criterios de inclusión: - Los pacientes deben poder proporcionar un formulario de consentimiento informado (ICF) por escrito - Deben estar dispuestos y ser capaces de completar instrumentos de Calidad de vida relacionada con la salud (Health-related quality of life, HRQoL) iniciales y de seguimiento, para los cuales los pacientes deben tener dominio del inglés o el español - Los pacientes con LMA deben tener al menos 55 años de edad al momento del consentimiento informado. - Los pacientes con MF, ICUS y SMD deben tener al menos 18 años de edad al momento del consentimiento informado . Citopenias idiopáticas de significado incierto (ICUS) de diagnóstico reciente, síndromes mielodisplásicos (SMD), pacientes con leucemia mieloide aguda (LMA): - Enfermedad primaria o secundaria de diagnóstico reciente. Considerarse "como recién diagnosticado", a patient's confirmed diagnosis must be made no more than 60 days prior to the date of consent signature. (An additional 5-day window [i.e., up to 65 days prior to the date of ICF signature] may be allowed in special circumstance upon sponsor approval) - Cohort assignment confirmed by central eligibility review. Cohort assignment must also be confirmed by the site. Myelofibrosis (MF) patients: - Patients who initiated their first active systemic treatment for MF and/or MF-related cytopenias within 90 days prior to the date of consent signature. This cohort allows the enrollment of subjects with a diagnosis of Myelodysplastic/Myeloproliferative overlap syndromes (MDS/MPN overlap syndrome). - Cohort assignment is confirmed by the site. Central eligibility review is not required. Treated Lower-Risk Myelodysplastic Syndromes (LR-MDS) patients: - Patients who have initiated first active treatment regimen containing at least one non-ESA therapy, within 90 days prior to ICF - Cohort assignment is confirmed by site. Central eligibility review is not required. Luspatercept treated patients: - Patient must have been at least 18 years of age at the start of luspatercept. - Among LR-MDS patients, patient must have initiated luspatercept on or after September 1, 2023, must be ESA-naïve and luspatercept must be the first active treatment (as monotherapy or part of a treatment regimen) for their disease. - Among all other myeloid malignancies, there is no date restriction for initiation of luspatercept .Patient may have received prior treatment for their disease. - Patient must have at least 3 months of follow-up from start of luspatercept treatment at the participating site. Exclusion Criteria: - Suspected or proven acute promyelocytic leukemia (APL) (FAB M3 or WHO 2008) based on morphology, immunophenotype, molecular assay or karyotype - Currently enrolled in any interventional clinical trial where the patient is being treated with an investigational product that cannot be identified. - Idiopathic Cytopenias of Undetermined Significance (ICUS), Myelodysplastic Syndromes (MDS) patients who received or are receiving active (disease modifying) therapy for the treatment of MDS prior to the date of informed consent. - Acute Myeloid Leukemia (AML) patients who initiated active (disease modifying treatment for AML more than 2 weeks prior to the date of consent. - Myelofibrosis (MF) and Myelodysplastic/Myeloproliferative (MDS/MPN) overlap syndrome patients with suspected juvenile myelomonocytic leukemia (JMML). Luspatercept treated patients: - Patient must not be currently or previously enrolled in the Connect Myeloid Registry. - Patient must not have received luspatercept as part of a clinical trial.

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