Registry Platform Hematologic Malignancies (RUBIN) - Extension of Tumor Registry Lymphatic Neoplasms

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Research Platform on Treatment, Quality of Life and Outcome of Patients With Hematologic Malignancies (RUBIN) - Extension of Tumor Registry Lymphatic Neoplasms

Conditions
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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)

Intervention / Treatment
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* Other: Routine care as per site standard.


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chronic Lymphocytic Leukemia (CLL)<br>Patients with CLL receiving systemic treatment (physician's choice) | Other: Routine care as per site standard.<br>* Physician's choice according to patient's needs.<br>|
| Diffuse Large B-cell Lymphoma (DLBCL)<br>Patients with DLBCL receiving systemic treatment (physician's choice) | Other: Routine care as per site standard.<br>* Physician's choice according to patient's needs.<br>|
| Follicular Lymphoma (FL)<br>Patients with FL receiving systemic treatment (physician's choice) | Other: Routine care as per site standard.<br>* Physician's choice according to patient's needs.<br>|
| Mantle Cell Lymphoma (MCL)<br>Patients with MCL receiving systemic treatment (physician's choice) | Other: Routine care as per site standard.<br>* Physician's choice according to patient's needs.<br>|
| Marginal Zone Lymphoma (MZL)<br>Patients with MZL receiving systemic treatment (physician's choice) | Other: Routine care as per site standard.<br>* Physician's choice according to patient's needs.<br>|
| Waldenström's macroglobulinemia (WM)<br>Patients with WM receiving systemic treatment (physician's choice) | Other: Routine care as per site standard.<br>* Physician's choice according to patient's needs.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Course of treatment (treatment reality) | Documentation of anamnestic data and therapy sequences. Documentation of anamnestic data and therapy sequences | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best Response | Documentation of response rates per line of treatment. | 5 years | 
| Progression-free survival | Documentation of progression-free survival per line of treatment. | 5 years | 
| Overall survival | Documentation of overall survival time. | 5 years | 
| Health-related quality of life (Patient-reported outcome) | EORTC QLQ-C30 core questionnaire | 1 year | 
| Disease-specific quality of life (Patient-reported outcome, patients with CLL) | EORTC QLQ-CLL17 | 1 year | 
| Disease-specific quality of life (Patient-reported outcome, patients with LG-NHL) | EORTC QLQ-NHL-LG20 | 1 year | 
| Disease-specific quality of life (Patient-reported outcome, patients with HG-NHL) | EORTC QLQ-NHL-HG29 | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-Hodgkin lymphoma (NHL)