Mantle-Cell Lymphoma
Conditions
Brief summary
The primary efficacy endpoint is the PFS at 12 months (end of C17) from first dose of study treatment as determined by imaging central review (Lugano 2014 criteria), Each cohort will be assessed independently.
Detailed description
Overall response rates (ORR) and complete response rates (CRR) as determined by investigator and by imaging central review,, PFS at 12 months (end of C17) from first dose of study treatment as determined by investigator (Lugano 2014 criteria). Each cohort will be assessed independently., Duration of response (DOR) according to investigator,, Event-free survival (EFS) according to investigator, Disease-free survival (DFS) according to investigator,, Overall survival (OS),, Time to next anti-lymphoma treatment (TTNT),, Safety and tolerability,, MRD response in peripheral blood,
Interventions
DRUGVENETOCLAX
DRUGOBINUTUZUMAB
DRUGGLOFITAMAB
DRUGZANUBRUTINIB
Sponsors
Lymphoma Academic Research Organisation
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy endpoint is the PFS at 12 months (end of C17) from first dose of study treatment as determined by imaging central review (Lugano 2014 criteria), Each cohort will be assessed independently. | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall response rates (ORR) and complete response rates (CRR) as determined by investigator and by imaging central review,, PFS at 12 months (end of C17) from first dose of study treatment as determined by investigator (Lugano 2014 criteria). Each cohort will be assessed independently., Duration of response (DOR) according to investigator,, Event-free survival (EFS) according to investigator, Disease-free survival (DFS) according to investigator,, Overall survival (OS),, Time to next anti-lymphoma treatment (TTNT),, Safety and tolerability,, MRD response in peripheral blood, | — |
Countries
Belgium, France
Outcome results
None listed