Diffuse large B-cell lymphoma (DLBCL)
Conditions
Brief summary
Safety run-in part: The primary endpoint is the recommended phase 2 dose after analysis of the first 12 patients treated. All patients: 2-year PFS with 95% CI of all patients treated.
Detailed description
Secondary endpoints for efficacy: OS, EFS, CR, PR, ORR, PD, DOR, rate of relapse, Outcome in molecular subtypes of DLBCL, Secondary endpoints for safety: Adverse events (AE), Serious AEs (SAE), Number of treatment related deaths, Incidence of secondary malignancies, Number and duration of therapy cycles, Cumulative doses of cyclophosphamide, doxorubicin, vincristine, rituximab and copanlisib
Interventions
Sponsors
Universitaetsklinikum Muenster AöR
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety run-in part: The primary endpoint is the recommended phase 2 dose after analysis of the first 12 patients treated. All patients: 2-year PFS with 95% CI of all patients treated. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints for efficacy: OS, EFS, CR, PR, ORR, PD, DOR, rate of relapse, Outcome in molecular subtypes of DLBCL, Secondary endpoints for safety: Adverse events (AE), Serious AEs (SAE), Number of treatment related deaths, Incidence of secondary malignancies, Number and duration of therapy cycles, Cumulative doses of cyclophosphamide, doxorubicin, vincristine, rituximab and copanlisib | — |
Countries
Germany
Outcome results
None listed