Generalized mantle cell Lymphoma
Conditions
Brief summary
FFS defined as time from randomization to stable disease at end of immuno-chemotherapy, progressive disease, or death from any cause.
Detailed description
Overall survival (OS), Progression-free survival (PFS) from randomization, from end of induction immuno-chemotherapy in patients with CR or PR at end of induction immuno-chemotherapy, and from the staging 6 weeks after end of induction assessment (at month 6), Overall response and complete remission rates at midterm, at end of induction, 3 months after end of induction immunochemotherapy (at month 6), PR to CR conversion rate during follow-up after end of induction immuno-chemotherapy, Rates of AEs, SAEs, and SUSARs by CTC grade (Version 4.03) during induction immuno-chemotherapy and during periods of follow-up after response to immune-chemotherapy, Cumulative incidence rates of SPMs
Interventions
DRUGIBRUTINIB
Sponsors
Klinikum der Universitaet Muenchen AöR
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| FFS defined as time from randomization to stable disease at end of immuno-chemotherapy, progressive disease, or death from any cause. | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS), Progression-free survival (PFS) from randomization, from end of induction immuno-chemotherapy in patients with CR or PR at end of induction immuno-chemotherapy, and from the staging 6 weeks after end of induction assessment (at month 6), Overall response and complete remission rates at midterm, at end of induction, 3 months after end of induction immunochemotherapy (at month 6), PR to CR conversion rate during follow-up after end of induction immuno-chemotherapy, Rates of AEs, SAEs, and SUSARs by CTC grade (Version 4.03) during induction immuno-chemotherapy and during periods of follow-up after response to immune-chemotherapy, Cumulative incidence rates of SPMs | — |
Countries
Belgium, Czechia, Denmark, Finland, Germany, Italy, Netherlands, Norway, Poland, Portugal, Spain, Sweden
Outcome results
None listed