Chronic Lymphocytic Leukemia (CLL), Diffuse Large B-cell Lymphoma (DLBCL), Follicular Lymphoma (FL), Mantle Cell Lymphoma (MCL), Marginal Zone Lymphoma (MZL), Waldenström's Macroglobulinemia (WM)
Conditions
Keywords
non-Hodgkin lymphoma (NHL)
Brief summary
The purpose of the project is to set up a national, prospective, longitudinal, multicenter registry platform to document uniform data on characteristics, molecular diagnostics, treatment and course of disease, to collect patient-reported outcomes and to establish a decentralized biobank for patients with hematological malignancies in Germany.
Detailed description
RUBIN is a national, observational, prospective, longitudinal, multicenter registry platform with the purpose to record information on the antineoplastic treatment of hematological malignancies in Germany. It will identify common therapeutic sequences and changes in the treatment of the disease, and will analyse the impact of novel treatments on the outcome of patients in routine care. Unmet needs and areas with the potential for improvement in routine care are to be identified. At inclusion, data in patient characteristics, comorbidities, clinical characteristics and previous treatments, if applicable, are collected. During the course of observation data on all systemic treatments, radiotherapies, surgeries, and clinical outcome are documented. Health-realted quality of life in patients with hematological malignancies will be evaluated for up to one year.
Interventions
Physician's choice according to patient's needs.
Sponsors
iOMEDICO AG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Confirmed diagnosis of the respective NHL * If patient is alive: signed written informed consent * For patients participating in the PRO survey: IC prior to or at day of start of respective line of treatment. * For patients not participating in the PRO survey: IC latest eight weeks after start of respective line of treatment.
Exclusion criteria
* No systemic therapy for respective lymphoid malignancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Course of treatment (treatment reality) | 5 years | Documentation of anamnestic data and therapy sequences. Documentation of anamnestic data and therapy sequences |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Best Response | 5 years | Documentation of response rates per line of treatment. |
| Progression-free survival | 5 years | Documentation of progression-free survival per line of treatment. |
| Overall survival | 5 years | Documentation of overall survival time. |
| Health-related quality of life (Patient-reported outcome) | 1 year | EORTC QLQ-C30 core questionnaire |
| Disease-specific quality of life (Patient-reported outcome, patients with CLL) | 1 year | EORTC QLQ-CLL17 |
| Disease-specific quality of life (Patient-reported outcome, patients with LG-NHL) | 1 year | EORTC QLQ-NHL-LG20 |
| Disease-specific quality of life (Patient-reported outcome, patients with HG-NHL) | 1 year | EORTC QLQ-NHL-HG29 |
Countries
Germany
Contacts
CONTACTMartina Jänicke, Dr.
STUDY_CHAIRRainer Claus, Prof. Dr.
Universitätsklinikum Augsburg, Germany
STUDY_CHAIRTobias Dechow
Studienzentrum Onkologie Ravensburg, Germany
STUDY_CHAIRPaul Graf La Rosée, Prof. Dr.
Schwarzwald-Baar Klinikum, Germany
STUDY_CHAIRJens Kisro, Dr.
Lübecker Onkologische Schwerpunktpraxis, Germany
STUDY_CHAIRPatrick Marschner, Dr.
Praxis für Interdisziplinäre Hämatologie und Onkologie, Freiburg, Germany
STUDY_CHAIRIngo Tamm, PD Dr.
Onkologische Schwerpunktpraxis Kurfürstendamm, Berlin, Germany
STUDY_CHAIRRobert Zeiser, Prof. Dr.
Universitätsklinikum Freiburg, Germany
Outcome results
None listed