Relapsed/refractory Richter Transformation (RT)
Conditions
Brief summary
The primary endpoint of ZUMA-25 as per the master protocol is response rates by central assessment as defined in each substudy. The primary end point of Substudy B (RT) is ORR, defined as the proportion of subjects who achieve a best response of either complete response (CR) or partial response (PR)., Response will be determined by central assessment per the Lugano Classification (Cheson et al 2014).
Detailed description
The secondary endpoints of ZUMA-25 as per the master protocol are: • CR rate by central assessment as defined in each substudy, • Duration of Response, • Overall Survival, • Progression-free survival, • Time to next treatment defined as the time from enrollment (for Full Analysis Set [FAS]) or brexucabtagene autoleucel infusion (for modified intention to treat [mITT]) to the initiation of subsequent anticancer therapy/treatment, • Time to first response from brexucabtagene autoleucel infusion to the first response as defined in the substudy, Substudy B (RT) specific secondary endpoints are:, •ORR, defined as the proportion of subjects who achieve a best response of either CR or PR. Response will be determined by investigator assessment per the Lugano Classification, •ORR, defined as the proportion of subjects who achieve a best response of either CR or PR by central assessment per the Lugano Classification, in subgroups by clonal relationship to the underlying CLL. Clonality will be assessed by central assessment, •ORR, defined as the proportion of subjects who achieve a best response of either CR, CR with incomplete marrow recovery (CRi), or PR per International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2018 criteria.
Interventions
DRUGVINCRISTINE
DRUGFLUDARABINE
DRUGPREDNISOLONE
DRUG-
DRUGIFOSFAMIDE
DRUGMETHYLPREDNISOLONE
DRUGETOPOSIDE
DRUGDOXORUBICIN
DRUGMESNA
DRUGCYCLOPHOSPHAMIDE
DRUGDEXAMETHASONE
DRUGOXALIPLATIN
DRUGGEMCITABINE
DRUGCARBOPLATIN
DRUGRITUXIMAB
Sponsors
Kite Pharma Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of ZUMA-25 as per the master protocol is response rates by central assessment as defined in each substudy. The primary end point of Substudy B (RT) is ORR, defined as the proportion of subjects who achieve a best response of either complete response (CR) or partial response (PR)., Response will be determined by central assessment per the Lugano Classification (Cheson et al 2014). | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints of ZUMA-25 as per the master protocol are: • CR rate by central assessment as defined in each substudy, • Duration of Response, • Overall Survival, • Progression-free survival, • Time to next treatment defined as the time from enrollment (for Full Analysis Set [FAS]) or brexucabtagene autoleucel infusion (for modified intention to treat [mITT]) to the initiation of subsequent anticancer therapy/treatment, • Time to first response from brexucabtagene autoleucel infusion to the first response as defined in the substudy, Substudy B (RT) specific secondary endpoints are:, •ORR, defined as the proportion of subjects who achieve a best response of either CR or PR. Response will be determined by investigator assessment per the Lugano Classification, •ORR, defined as the proportion of subjects who achieve a best response of either CR or PR by central assessment per the Lugano Classification, in subgroups by clonal relationship to the underlying CLL. Clonality will be as | — |
Countries
Austria, France, Germany, Italy, Netherlands, Spain, Sweden
Outcome results
None listed