Richter´syndrome
Conditions
Brief summary
Primary end point will be CR evaluated by an independent review committee according to modified Lugano classification using PET/CT scan (Cheson et al. 2014) at 8-12 weeks after the EoI visit. CR will be defined as a score of 1, 2 or 3 for lymph nodes and extra-lymphatic sites at PET without new lesions and no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow. All PET evaluable patients with at least one dose of Mosunetuzumab will be included in the efficacy population.
Detailed description
Objective response rate (ORR),Complete remission rate (CR), Best overall response, Minimal residual disease (MRD), Progression free survival (PFS),Overall survival (OS), Duration of response (DOR),, Incidence and severity of adverse events, including for CRS, severity determined according to ASTCT CRS consensus grading criteria (Lee et al 2019); for TLS, presence of laboratory and/or clinical TLS determined according to Howard criteria (Howard et al 2011)., Study treatment exposure (such as treatment duration, total dose received, and number of cycles and dose modifications), Relationship between molecular and genetic prognostic factors as well as clonality and efficacy endpoints, Relationship between MRD response and efficacy endpoints such as PFS and OS.
Interventions
DRUGVincristina Pfizer 1 mg/ml solución inyectable EFG
DRUGDoxorrubicina Accord 2 mg/ml Concentrado para solução para perfusão
DRUGLunsumio 30 mg concentrate for solution for infusion
DRUGprednisona cinfa 2
DRUG5 mg comprimidos EFG
Sponsors
Grupo Espanol De Leucemia Linfocitica Cronica
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point will be CR evaluated by an independent review committee according to modified Lugano classification using PET/CT scan (Cheson et al. 2014) at 8-12 weeks after the EoI visit. CR will be defined as a score of 1, 2 or 3 for lymph nodes and extra-lymphatic sites at PET without new lesions and no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow. All PET evaluable patients with at least one dose of Mosunetuzumab will be included in the efficacy population. | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR),Complete remission rate (CR), Best overall response, Minimal residual disease (MRD), Progression free survival (PFS),Overall survival (OS), Duration of response (DOR),, Incidence and severity of adverse events, including for CRS, severity determined according to ASTCT CRS consensus grading criteria (Lee et al 2019); for TLS, presence of laboratory and/or clinical TLS determined according to Howard criteria (Howard et al 2011)., Study treatment exposure (such as treatment duration, total dose received, and number of cycles and dose modifications), Relationship between molecular and genetic prognostic factors as well as clonality and efficacy endpoints, Relationship between MRD response and efficacy endpoints such as PFS and OS. | — |
Countries
Spain
Outcome results
None listed