Patologia: Neoplasie ematologiche
Osservazionale-Sperimentale: Sperimentale
Monocentrico-Multicentrico: Multicentrico
Randomizzato: Sì
Fase di studio: III
Linee di trattamento: Seconda linea, Terza/N linea
Criteri di inclusione:
- Has a diagnosis of ET per WHO 2016 diagnostic criteria for myeloproliferative neoplasms
- Has a 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: hydroxyurea resistance (or inadequate response) or hydroxyurea 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 lines of therapy including hydroxyurea.
Criteri di esclusione:
- 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.
Trattamento sperimentale:
DRUG: Bomedemstat
DRUG: Anagrelide
DRUG: Busulfan
DRUG: Interferon alfa/pegylated interferon alfa
DRUG: Ruxolitinib
Trattamento di controllo:
Best Available Therapy
AO SS Antonio e Biagio e C. Arrigo
Via Venezia 16 - 15100 Alessandria - AL
Azienda Ospedaliero Universitaria di Ferrara
Via Aldo Moro 8 - 44124 Cona - FE
Arcispedale Sant'Anna
Email: sse@unife.it
IRCCS - IRST Meldola Dino Amadori
Via P. Maroncelli 40 - 47014 Meldola - FC
IRCCS Ca' Granda Ospedale Maggiore Policlinico
Via Francesco Sforza 35 - 20122 Milano - MI
Ematologia
Telefono: 0255033422
Email: ematologia@policlinico.mi.it
AUSL/IRCCS di Reggio Emilia
Viale Risorgimento 80 - 42123 Reggio nell'Emilia - RE
Arcispedale Santa Maria Nuova
AO - Ordine Mauriziano
Largo Turati 62 - 10128 Torino - TO
Ospedale di Circolo Fondazione Macchi
Viale Luigi Borri 57 - 21100 Varese - VA
Ospedale Riuniti Umberto I - Lancisi-Salesi
Via Conca 71 - 60020 Ancona - AN
Riferimento: Dr.ssa Serena Rupoli
Telefono: 3495328389
Email: serena.rupoli@ospedaliriuniti.marche.it
AOU Careggi
Largo Brambilla 3 - 50134 Firenze - FI
Email: crimm@aou-careggi.toscana.it
Numero di iscrizione a registro: 2023-504865-21
Data di inserimento: 27.06.2024
Data di aggiornamento: 23.09.2024
Merck Sharp & Dohme LLC
Riferimento: Dr. Info non applicabile
Telefono: 00000
Email: na@na.it
Localita: na