Mantle Cell Lymphoma
Conditions
Brief summary
To evaluate efficacy in both treatment arms: Failure-Free Survival (FFS) at 30 months
Detailed description
Failure-free survival (continuous observation), Progression-free survival, Complete Remission rate (CR) and overall response rate (ORR: CR, PR) four weeks after the end of induction therapy, best response, time to best response, time to first response, overall survival, Overall survival of patients divided according to the geriatric categories and treatment received, Safety: adverse events, tolerability, Quality of life during induction and maintenance therapy (assessed using the EORTC QLQ-C30 and the EORTC QLQ-NHL-HG29), Molecular remission after induction and conversion during maintenance (exploratory), Immune reconstitution, e.g. persistence of anti-Covid19 immunity, safety and efficacy in different geriatric categories
Interventions
Sponsors
Universitatsmedizin der Johannes Gutenberg-Universitat Mainz KöR
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate efficacy in both treatment arms: Failure-Free Survival (FFS) at 30 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Failure-free survival (continuous observation), Progression-free survival, Complete Remission rate (CR) and overall response rate (ORR: CR, PR) four weeks after the end of induction therapy, best response, time to best response, time to first response, overall survival, Overall survival of patients divided according to the geriatric categories and treatment received, Safety: adverse events, tolerability, Quality of life during induction and maintenance therapy (assessed using the EORTC QLQ-C30 and the EORTC QLQ-NHL-HG29), Molecular remission after induction and conversion during maintenance (exploratory), Immune reconstitution, e.g. persistence of anti-Covid19 immunity, safety and efficacy in different geriatric categories | — |
Countries
Germany, Italy
Outcome results
None listed