ORPHA:52416 C83.1
Conditions
Interventions
Group 1: In the EMCL registry, data on the sequential treatment regime of patients with mantle cell lymphoma (MCL) are collected pro- and retrospectively. All patients diagnosed with mantle cell lymph
Sponsors
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Mantle cell lymphoma Informed consent with the exception of deceased patients
Exclusion criteria
Exclusion criteria: Lymphoma other than MCL
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Understand the disease course of mantle cell lymphoma (MCL) and it variants with the use of different treatment modalities or different treatment sequencing | — |
Secondary
| Measure | Time frame |
|---|---|
| * Describe patient characteristics * Describe existing and identify clinical and molecular risk factors * Evaluate impact of comorbidity scores (e.g. Charlson, HCT-CI) on outcome * Describe pathological profiles * Describe pattern and completeness of diagnostic procedures: clinical, laboratory, pathological * Describe patterns of treatments used in different lines within different treatment periods * Understand scope of responses to sequentially applied treatments * Develop a prediction model for selection of ideal treatments for individual patients * Evaluate prognostic scoring systems in distinct subpopulations * Collect and analyze real world data on progression free survival on various drugs * Collect and analyze real world data on overall survival * Collect and analyze real world data on healthcare resource utilization * Collect and analyze Quality of life (QoL) QoL analysis are highly relevant and attractive (defined prospective cohort) * Analyze adverse event profiles in dedicated and representative patient populations, distinct from clinical research cohorts using a defined set of clinically relevant events, which may be defined in relation to specific projects within the protocol * Understand the pattern of clinically meaningful adverse events and late sequalae of treatment * Integrate long term follow up of clinical trials * Monitor efficacy and safety of novel therapeutic option with real world data | — |
Countries
Croatia, Egypt, Germany, Ireland, Italy, Portugal, Spain, Switzerland
Outcome results
None listed