A Phase 3, Randomized, Open-label, Active-Comparator-Controlled Clinical Study to Evaluate the Safety and Efficacy of Bomedemstat (MK-3543/IMG-7289) Versus Best Available Therapy (BAT) in Participants With Essential Thrombocythemia Who Have an Inadequate Response to or Are Intolerant of Hydroxyurea

ReclutandoFase 3ClinicalTrials.gov

ID: NCT06079879Tipo: INTERVENTIONALInicio: 31 de dic de 2023Fin estimado: 18 de ago de 2028

Traducción no disponible, mostrando original

Resumen

This is a study evaluating the safety and efficacy of bomedemstat (MK-3543) compared with the best available therapy (BAT) in participants with essential thrombocythemia (ET) who have an inadequate response to or are intolerant of hydroxyurea. The primary study hypothesis is that bomedemstat is superior to the best available therapy with respect to durable clinicohematologic response (DCHR).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Has a diagnosis of ET per WHO 2016 diagnostic criteria for myeloproliferative neoplasms (confirmed by a central pathologist)
Has a centrally assessed bone marrow fibrosis score of Grade 0 or Grade 1, as per a modified version of the European Consensus Criteria for Grading Myelofibrosis
Has a history of inadequate response to or intolerance of hydroxyurea based on modified European LeukemiaNet (ELN) criteria for hydroxyurea resistance or intolerance
Has an inadequate or loss of response to their most recent prior ET therapy, requiring a change of cytoreductive therapy
Has a platelet count \> 450 × 10\^9/L (450k /μL) assessed up to 72 hours before first dose of study intervention
Has an absolute neutrophil count (ANC) ≥0.75 × 10\^9/L assessed up to 72 hours before first dose of study intervention
Participants may have received up to 3 prior ET-directed cytoreductive agents including hydroxyurea

Criterios de exclusión

Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to bomedemstat or lysine demethylase or monoamine oxidase inhibitor (LSDi or MAOi) or the chosen best available therapy (including anagrelide, interferon alfa/pegylated interferon, ruxolitinib, or busulfan) that contraindicates participation
History of any illness/impairment of GI function that might interfere with drug absorption (eg, chronic diarrhea or history of gastric bypass surgical procedure), confound the study results or pose an additional risk to the individual by participation in the study
Evidence at the time of Screening of increased risk of bleeding
History of a malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years. Note: The time requirement does not apply to participants who underwent successful definitive resection of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ, excluding carcinoma in situ of the bladder
Human immunodeficiency virus (HIV)-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease

Intervenciones

drug

Bomedemstat

Oral Capsule

drug

Anagrelide

Oral Capsule

drug

Busulfan

Oral Tablet

drug

Interferon alfa/pegylated interferon alfa 2a/pegylated interferon alfa 2b

Subcutaneous Solution

drug

Ruxolitinib

Oral Tablet

Ubicaciones

Hospital Universitario Austral ( Site 0104)

Pilar, Buenos Aires, Argentina

Study Coordinator · +542304388888

RECRUITING

Hospital Italiano de Buenos Aires ( Site 0105)

ABB, Buenos Aires F.D., Argentina

Study Coordinator · +541149590200

RECRUITING

C.I.C.E. 9 de Julio ( Site 1001)

San Miguel de Tucumán, Tucumán Province, Argentina

Study Coordinator · +543814524400

RECRUITING

Patrocinadores

PrincipalMerck Sharp & Dohme LLC

Contactos

Toll Free Number

CONTACT

Trialsites@msd.com 1-888-577-8839

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

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