Polatuzumab Vedotin Plus Rituximab, Ifosfamide, Carboplatin and Etoposide (Pola-R-ICE) Versus R-ICE Alone in Second Line Treatment of Diffuse Large B-cell Lymphoma (DLBCL)
1. Assessment of the event-free survival of patients with DLBCL at first progression and the occurrence of any of the following events: (Time Frame - Day of randomization until end of follow up (12 weeks treatment and at least 21 months follow up)): Failure to achieve sufficient response in PET-CT (Deauville score 3 or less) at end of study treatment (metabolic CR)
Disease progression (PD)
Start of additional unplanned anti-tumor treatment (radiation therapy allowed)
Relapse after achieving CR
Death due to any cause
Secondary outcome:
1. Assessment of the rate of metabolic complete response. (Time Frame - Day of randomization until end weeks 12 treatment.): Number of complete remissions.
2. Evaluation of the partial response rate. (Time Frame - Day of randomization until end of 12 weeks treatment.): Number of partial responses.
3. Assessment of the overall response rate. (Time Frame - Day of randomization until end of 12 weeks treatment.): Number of complete and partial responses.
4. Assessment duration of response. (Time Frame - Day of randomization until end of follow up (12 weeks treatment and at least 21 months follow up)): Time from documentation of tumor response to disease progression or relapse.
5. Assessment of the rate of progressive disease. (Time Frame - Day of randomization until end of 12 weeks treatment.): Number of progressive diseases.
6. Assessment of disease relapse. (Time Frame - Day of randomization until end of 12 weeks treatment.): Number of relapses.
7. Assessment of progression free survival. (Time Frame - Day of randomization until end of follow up (12 weeks treatment and at least 21 months follow up)): Occurence of disease progression, relapse or death due to any cause.
8. Assessment of overall survival. (Time Frame - Day of randomization until end of follow up (12 weeks treatment and at least 21 months follow up))
9. Assessment of the rate of patients proceeding to transplantation. (Time Frame - Day of randomization until week 12.)
10. Assessment of the rate of patients with non-relapse mortality. (Time Frame - Day of randomization until end of follow up (12 weeks treatment and at least 21 months follow up))
11. Evaluation of the frequency of adverse and serious adverse events including the incidence and duration of the adverse events neutropenia and thrombocytopenia with grade 4. (Time Frame - Day of Randomization until 28 days after start of last cycle or start of further therapy)
12. Assessment of the number of patients with treatment-related death. (Time Frame - Day of Randomization until up week 12 or 2 months after week 12 but before start of further therapy)
13. To determine the number of patients with occurence of second malignancies (Time Frame - Day of Randomization until Day of randomization until end of follow up (at least 21 months follow up))
14. Assessment of the protocol adherence by the rate and duration of chemotherapy cycles patients received. (Time Frame - Day of Randomizaton until week 12.)
15. Assessment of the cumulative and relative dose of each IMP( ifosfamide, carboplatin and etoposide, rituximab and of the polatuzumab vedotin) by quantitative measurement. (Time Frame - Day of Randomizaton until week 12.)
16. Assessment of the change in health related quality of life by generic questionnaire. (Time Frame - Day of Randomization until weeks 12 and months 3 and 12 in follow up.): Scale scores to be obtained for the multi-items scales. Range in score from 0 to 100. A high scale score represents a higher response level.
17. Assessment of the change in health related quality of life by five-item questionnaire. (Time Frame - Day of Randomization until weeks 12 and months 3 and 12 in follow up)
18. Assessment visual analogue scale to measure health state. (Time Frame - Day of Randomization until weeks 12 and months 3 and 12 in follow up): This scale is provided with numbers from 0 to 100.100 is the best health state and 0 (zero) is the worst health state.
19. Functional assessment of the cancer therapy-lymphoma by general questions and specific questions for lymphoma. (Time Frame - Day of Randomization until weeks 12 and months 3 and 12 in follow up.): Assessment how lymphoma-specific symptoms impact quality of life.
Polatuzumab Vedotin: Polatuzumab vedotin 1.8 mg/kg will be administered intravenously on Day 1 of each 21-day cycle for up to 3 cycles.
Mabthera: Rituximab (Mabthera/Rituxan®) will be administered as per local practice at a dose of 375 mg/m2 intravenously on Day 1 of each 21-day cycle for up to 3 cycles.
Ifosfamide: Ifosfamide 5000 mg/m² will be administered i.v. over a 24 hr period starting on cycle Day 2.
Carboplatin: Carboplatin AUC 5 max 800 mg will be administered i.v. on cycle Day 2.
Etoposide: Etoposide 100 mg/m² will be administered i.v. on cycle Days 1, 2 and 3.
Quelle: ClinicalTrials.gov
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