A Study of Tacabrutideg (BGB-16673) Compared to Investigator's Choice in Participants With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both Bruton Tyrosine Kinase (BTK) and B-cell Leukemia/Lymphoma 2 Protein (BCL2) Inhibitors
A legfontosabb adatok
- Hol
- Greenfield Park, Hamilton, London, Montreal, Ottawa és SaintJerome (Kanada)Mind a 6 helyszín megnézése
- Fázis
- 3. fázis
Helyszínek itt: Kanada
- Centre Intégré de Santé et de Services Sociaux de la Montérégie-CentreGreenfield Park, KanadaContact: Study DirectorRésztvevőt keres
- Juravinski Cancer CentreHamilton, KanadaContact: Study DirectorRésztvevőt keres
- London Health Sciences CentreLondon, KanadaContact: Study DirectorRésztvevőt keres
- Jewish General HospitalMontreal, KanadaContact: Study DirectorRésztvevőt keres
- The Ottawa Hospital Cancer CentreOttawa, KanadaContact: Study DirectorRésztvevőt keres
- Unite de Recherche Clinique Du Cisss Des LaurentidesSaintJerome, KanadaContact: Study DirectorRésztvevőt keres
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- BeOne Medicines
- Azonosító
- NCT06846671EU 2024-518893-15-00
- A regiszteradat frissítve
- 2026. november 12.
- Eredeti leírás
The purpose of this study is to investigate the efficacy and safety of tacabrutideg compared with investigator's choice (idelalisib plus rituximab [for CLL only] or bendamustine plus rituximab or venetoclax plus rituximab retreatment) in participants with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) previously exposed to both BTK inhibitors (BTKi) and BCL2 inhibitors (BCL2i).A teljes eredeti leírásKevesebb
A Phase 3, Open-Label, Randomized Study of BGB-16673 Compared to Investigator's Choice (Idelalisib Plus Rituximab or Bendamustine Plus Rituximab or Venetoclax Plus Rituximab Retreatment) in Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both BTK and BCL2 Inhibitors
The purpose of this study is to investigate the efficacy and safety of tacabrutideg compared with investigator's choice (idelalisib plus rituximab [for CLL only] or bendamustine plus rituximab or venetoclax plus rituximab retreatment) in participants with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) previously exposed to both BTK inhibitors (BTKi) and BCL2 inhibitors (BCL2i).
Bevonási feltételek: Confirmed diagnosis of CLL or SLL, requiring treatment, based on 2018 international workshop on chronic lymphocytic leukemia (iwCLL) criteria; Previously received treatment for CLL/SLL with both a BTKi and a BCL2i; Participants with SLL must have measurable disease by computer tomography (CT)/magnetic resonance imaging (MRI); Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2; Adequate liver function; Adequate blood clotting function.
Kizáró feltételek: Prior autologous stem cell transplant or chimeric antigen receptor-T cell therapy in the last 6 months; Prior exposure to any BTK protein degraders; Receiving systemic immunosuppressive therapy for a nonmalignant condition within 28 days before the first dose of study treatment; NOTE: Other protocol defined Inclusion/Exclusion criteria may apply; Active fungal, bacterial and/or viral infection requiring parenteral systemic therapy; Clinically significant cardiovascular disease; Prior invasive fungal infection, except if patient agrees to receive secondary antifungal prophylaxis during the entire treatment period; Known contraindications to azole antifungal agents, including hypersensitivity reactions; Known prolymphocytic leukemia (defined per iwCLL 2018 as prolymphocytes comprising >55% of peripheral blood lymphocytes), or currently suspected or history of Richter's transformation within the last 5 years; Known central nervous system involvement.