High risk Follicular Lymphoma (FL) patients treated by R-CHOP, Newly diagnosed Diffuse Large B Cell Lymphoma
Conditions
Brief summary
Incidence and severity of treatment-emergent AEs qualifying as protocol defined DLT’s in cycle 1 and 2 in order to establish the MTD/RP2D
Detailed description
PK parameters: maximum plasma concentration (Cmax), time to Cmax (tmax), area under the concentration-time curve from time 0 to last measurable concentration [AUC(0-t)], area under the concentration-time curve from time 0 to 12 hours post-dose [AUC(0-12)], and elimination half-life (t1/2) of cyclophosphamide, prednisolone, doxorubicin, doxorubicinol, methyl prednisolone, prednisone, vincristine, tazemetostat, and EPZ-6930, if data permit, Complete response rate as determined by Cheson IWG 2014: Lugano Classification (Deauville scale 1-3)
Interventions
DRUGPREDNISOLONE
DRUGCYCLOPHOSPHAMIDE
DRUGRITUXIMAB
DRUGDOXORUBICIN
DRUGTAZEMETOSTAT
DRUGVINCRISTINE
Sponsors
LYSARC
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of treatment-emergent AEs qualifying as protocol defined DLT’s in cycle 1 and 2 in order to establish the MTD/RP2D | — |
Secondary
| Measure | Time frame |
|---|---|
| PK parameters: maximum plasma concentration (Cmax), time to Cmax (tmax), area under the concentration-time curve from time 0 to last measurable concentration [AUC(0-t)], area under the concentration-time curve from time 0 to 12 hours post-dose [AUC(0-12)], and elimination half-life (t1/2) of cyclophosphamide, prednisolone, doxorubicin, doxorubicinol, methyl prednisolone, prednisone, vincristine, tazemetostat, and EPZ-6930, if data permit, Complete response rate as determined by Cheson IWG 2014: Lugano Classification (Deauville scale 1-3) | — |
Countries
Belgium, France
Outcome results
None listed