Chronic Lymphocytic Leukemia
Conditions
Brief summary
Monotherapy Cohorts (R/R CLL) • Incidence of DLTs • Incidence and severity of AEs and SAEs. • Incidence and severity of CRS, ICANS and TLS, Monotherapy (R/R CLL [Arm 1 and 1A] and RS [Arm 2A]): • ORR, Dose Escalation Venetoclax Combination Therapy (R/R CLL) • Incidence of DLTs • Incidence and severity of AEs, Expansion Venetoclax Combination Therapy in R/R CLL (Arm 3) • ORR as assessed by the IRC, Expansion Lenalidomide Combination Therapy in RS (Arm 2B) and R CHOP Combination Therapy in RS (Arm 2C) • ORR as assessed by the IRC
Detailed description
Monotherapy (R/R CLL [Arm 1] and RS [Arm 2A]), Expansion Lenalidomide Combination Therapy in RS (Arm 2B) and R CHOP Combination Therapy in RS (Arm 2C): • DOR • CR rate (both cohorts)/CRi rate (CLL cohort only) • PR/nPR rate • TTR • PFS • OS • TTNT • Incidence and severity of AEs and SAEs. • Incidence and severity of CRS, ICANS, and CTLS • PK parameters • Incidence of overall MRD negativity • Duration of MRD negativity • Incidence of ADAs to epcoritamab, Dose Escalation Venetoclax Combination Therapy (R/R CLL) • ORR • DOR • CR/CRi rate • TTR • PFS • OS • TTNT • PK parameters • Incidence of overall MRD negativity • Duration of MRD negativity • Incidence of ADAs to epcoritamab, Safety Run-in Pirtobrutinib Combination Therapy (R/R CLL – Cohort CP1) • ORR • DOR • CR/CRi rate • TTR • PFS • OS • TTNT • PK parameters • Incidence of overall MRD negativity • Incidence of MRD negativity 3 months after Day 1 of last cycle • Duration of MRD negativity • Incidence of ADAs to epcoritamab, Expansion Pirtobrutinib Combination Therapy in R/R CLL (Arm 4) • ORR • DOR • CR/CRi rate • TTR • PFS • OS • TTNT • Incidence and severity of AEs and SAEs • Incidence and severity of CRS, ICANS, and CTLS • PK parameters • Incidence of overall MRD negativity • Incidence of MRD negativity 3 months after Day 1 of last cycle • Duration of MRD negativity • Incidence of ADAs to epcoritamab
Interventions
DRUGJaypirca 50 mg film-coated tablets
DRUGEpcoritamab
DRUGPREDNISOLONE
DRUGCYCLOPHOSPHAMIDE
DRUGRITUXIMAB
DRUGVENETOCLAX
DRUGVINCRISTINE
DRUGDOXORUBICIN
DRUGLENALIDOMIDE
Sponsors
Genmab A/S
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Monotherapy Cohorts (R/R CLL) • Incidence of DLTs • Incidence and severity of AEs and SAEs. • Incidence and severity of CRS, ICANS and TLS, Monotherapy (R/R CLL [Arm 1 and 1A] and RS [Arm 2A]): • ORR, Dose Escalation Venetoclax Combination Therapy (R/R CLL) • Incidence of DLTs • Incidence and severity of AEs, Expansion Venetoclax Combination Therapy in R/R CLL (Arm 3) • ORR as assessed by the IRC, Expansion Lenalidomide Combination Therapy in RS (Arm 2B) and R CHOP Combination Therapy in RS (Arm 2C) • ORR as assessed by the IRC | — |
Secondary
| Measure | Time frame |
|---|---|
| Monotherapy (R/R CLL [Arm 1] and RS [Arm 2A]), Expansion Lenalidomide Combination Therapy in RS (Arm 2B) and R CHOP Combination Therapy in RS (Arm 2C): • DOR • CR rate (both cohorts)/CRi rate (CLL cohort only) • PR/nPR rate • TTR • PFS • OS • TTNT • Incidence and severity of AEs and SAEs. • Incidence and severity of CRS, ICANS, and CTLS • PK parameters • Incidence of overall MRD negativity • Duration of MRD negativity • Incidence of ADAs to epcoritamab, Dose Escalation Venetoclax Combination Therapy (R/R CLL) • ORR • DOR • CR/CRi rate • TTR • PFS • OS • TTNT • PK parameters • Incidence of overall MRD negativity • Duration of MRD negativity • Incidence of ADAs to epcoritamab, Safety Run-in Pirtobrutinib Combination Therapy (R/R CLL – Cohort CP1) • ORR • DOR • CR/CRi rate • TTR • PFS • OS • TTNT • PK parameters • Incidence of overall MRD negativity • Incidence of MRD negativity 3 months after Day 1 of last cycle • Duration of MRD negativity • Incidence of ADAs to epcoritamab, Expansion | — |
Countries
Belgium, Czechia, Denmark, France, Germany, Italy, Netherlands, Poland, Spain
Outcome results
None listed