Lymphoma of B-cell origin
Conditions
Brief summary
Dose Escalation Phase: - Incidence of dose-limiting toxicities - Incidence and severity of adverse events (AEs) - Incidence and severity of changes in laboratory values - Incidence of dose interruptions and delays, Expansion Phase: Arms 1-6 and 8-10: - ORR determined by Lugano criteria Arm 7: - Incidence and severity of AEs - Incidence and severity of changes in laboratory values - Incidence of dose interruptions and delays
Detailed description
Dose Escalation Phase:- PK parameters- Pharmacodynamic markers in blood samples and within tumor (ontreatment biopsy)- Incidence of anti-drug antibodies (ADAs) to epcoritamab- ORR determined by Lugano criteria- Duration of response (DOR) determined by Lugano criteria- Time to response (TTR) determined by Lugano criteria- Progression-free survival (PFS) determined by Lugano criteria- Overall survival (OS)- TTNT- Rate and duration of minimal residual disease (MRD) negativity, Expansion Phase:-DOR determined by Lugano criteria (Arms 1-6 and 8-10)-TTR determined by Lugano criteria (Arms 1-6 and 8-10)-PFS determined by Lugano criteria (Arms 1-6 and 8-10)-CR rate (Arm 1-10 except Arm 7 subjects in CR at baseline)-OS (Arms 1-10)-TTNT (Arms 1-10)-Rate and duration of MRD negativity (Arms 1-10)-Rate of conversion from MRD positivity to MRD negativity (Arm 7)-CR rate (Arm 7 subjects in PR at baseline)-TTCR (Arms 1-10 except Arm 7 subjects in CR at baseline)-DoCR (Arms 1-10), Incidence and severity of AEs (Arms 1-6, and 8-10) -Incidence and severity of changes in laboratory values (Arms 1-6, and 8-10) -Incidence of dose interruptions and delays (Arms 1-6, and 8-10), PK parameters, Pharmacodynamic markers in blood samples and within tumor (on treatment biopsy), Incidence of ADAs to epcoritamab
Interventions
DRUGPARACETAMOL
DRUGGEMCITABINE
DRUGDOXORUBICIN
DRUGDEXAMETHASONE
DRUGSILTUXIMAB
DRUGPREDNISOLONE
DRUGANAKINRA
DRUGIFOSFAMIDE
DRUGVINCRISTINE
DRUGCYCLOPHOSPHAMIDE
DRUGEpcoritamab
DRUGOXALIPLATIN
DRUGBENDAMUSTINE
DRUGCYTARABINE
DRUGDIPHENHYDRAMINE
DRUGETOPOSIDE
DRUGPREDNISONE
DRUGLENALIDOMIDE
DRUGRITUXIMAB
DRUGTOCILIZUMAB
DRUGCARBOPLATIN
Sponsors
Genmab A/S
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose Escalation Phase: - Incidence of dose-limiting toxicities - Incidence and severity of adverse events (AEs) - Incidence and severity of changes in laboratory values - Incidence of dose interruptions and delays, Expansion Phase: Arms 1-6 and 8-10: - ORR determined by Lugano criteria Arm 7: - Incidence and severity of AEs - Incidence and severity of changes in laboratory values - Incidence of dose interruptions and delays | — |
Secondary
| Measure | Time frame |
|---|---|
| Dose Escalation Phase:- PK parameters- Pharmacodynamic markers in blood samples and within tumor (ontreatment biopsy)- Incidence of anti-drug antibodies (ADAs) to epcoritamab- ORR determined by Lugano criteria- Duration of response (DOR) determined by Lugano criteria- Time to response (TTR) determined by Lugano criteria- Progression-free survival (PFS) determined by Lugano criteria- Overall survival (OS)- TTNT- Rate and duration of minimal residual disease (MRD) negativity, Expansion Phase:-DOR determined by Lugano criteria (Arms 1-6 and 8-10)-TTR determined by Lugano criteria (Arms 1-6 and 8-10)-PFS determined by Lugano criteria (Arms 1-6 and 8-10)-CR rate (Arm 1-10 except Arm 7 subjects in CR at baseline)-OS (Arms 1-10)-TTNT (Arms 1-10)-Rate and duration of MRD negativity (Arms 1-10)-Rate of conversion from MRD positivity to MRD negativity (Arm 7)-CR rate (Arm 7 subjects in PR at baseline)-TTCR (Arms 1-10 except Arm 7 subjects in CR at baseline)-DoCR (Arms 1-10), Incidence and severi | — |
Countries
Belgium, Czechia, Denmark, Finland, France, Italy, Netherlands, Norway, Spain, Sweden
Outcome results
None listed