Patologia: Neoplasie ematologiche
Osservazionale-Sperimentale: Sperimentale
Monocentrico-Multicentrico: Multicentrico
Randomizzato: No
Fase di studio: II
Linee di trattamento: Seconda linea, Terza/N linea
Criteri di inclusione:
- Clinical and definitive histologic diagnosis of WM.
- Meeting ≥ 1 criterion for treatment according to consensus panel criteria from the 2nd International Workshop on Waldenström's Macroglobulinemia (IWWM).
- For Cohorts 1-3, refractory or relapsed disease to the most recent therapy at study entry unless participants had intolerance to the most recent therapy. Refractory disease is defined as not attaining at least a major response, or progressing while on or within 6 months of completing therapy. Relapsed disease is defined as attaining at least a major response to therapy and meeting the criteria for disease progression beyond 6 months after completing therapy.
- For Cohort 4, patients must not have received prior therapy for WM.
- Adequate organ function.
Criteri di esclusione:
- Central nervous system (CNS) involvement by WM.
- Transformation to aggressive lymphoma, such as diffuse large B-cell lymphoma.
- History of other malignancies ≤ 2 years before study entry.
- Uncontrolled active systemic infection or recent infection requiring parenteral antimicrobial therapy that was completed ≤ 14 days before the first dose of the study drug.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trattamento sperimentale:
BGB-11417 (Sonrotoclax).
Trattamento di controllo:
NA
Note generali:
N.B. Linee di trattamento: dalla seconda/terza linea in base alle coorti.
Grande Ospedale Metropolitano Niguarda
Piazza Ospedale Maggiore 3 - 20162 Milano - MI
Ematologia
Email: ematologia@ospedaleniguarda.it
IRCCS Policlinico San Matteo
Viale Golgi 19 - 27100 Pavia - PV
SC Ematologia 1 - Dipartimento Oncologia
Email: ematologia@smatteo.pv.it
Numero di iscrizione a registro: 2023-503235-18-00 - NCT05952037
Data di inserimento: 31.10.2024
BeiGene
Riferimento: Dr. Info non applicabile
Telefono: 00000
Email: na@na.it
Localita: na