Richter syndrome of chronic lymphocytic leukemia
Conditions
Brief summary
The treatment will be considered effective if the combination enables the achievement of a minimum of 67% ORR at the end of the sixth cycle. Patients will be evaluated according to Lugano Criteria for aggressive lymphomas (Cheson et al. JCO, 2014). Residual underlying CLL may persist in node and/or marrow and still qualify as CR, denoting complete response of RT to treatment (Hallek M et al. IwCLL Criteria Blood 2008).
Detailed description
Incidence of adverse events (AE) and serious adverse event (SAE) as measured per NCICTCAE v4.0; significant laboratory abnormality and dose tolerability (dose modifications and discontinuation)., Assessment of the efficacy of the combination of obinutuzumab, atezolizumab and venetoclax with respect to: - Complete Remission Rate (CRR) - Duration of Response (DoR) - Progression Free Survival (PFS) - Overall Survival (OS).
Interventions
Sponsors
ASST Grande Ospedale Metropolitano Niguarda
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The treatment will be considered effective if the combination enables the achievement of a minimum of 67% ORR at the end of the sixth cycle. Patients will be evaluated according to Lugano Criteria for aggressive lymphomas (Cheson et al. JCO, 2014). Residual underlying CLL may persist in node and/or marrow and still qualify as CR, denoting complete response of RT to treatment (Hallek M et al. IwCLL Criteria Blood 2008). | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse events (AE) and serious adverse event (SAE) as measured per NCICTCAE v4.0; significant laboratory abnormality and dose tolerability (dose modifications and discontinuation)., Assessment of the efficacy of the combination of obinutuzumab, atezolizumab and venetoclax with respect to: - Complete Remission Rate (CRR) - Duration of Response (DoR) - Progression Free Survival (PFS) - Overall Survival (OS). | — |
Countries
Italy
Outcome results
None listed