RUBINRecruiting

An observational study to collect treatment data for the long-term optimization of treatment in non-Hodgkin B-cell lymphomas

Gender
Women and men
Age
18 years and older
Trial type
Observational
Line of therapy
all
Phase
Phase IV

What is this trial about?

B-cell lymphomas are malignant diseases of the lymphatic system. To further improve treatment, it is important to collect treatment data in a structured manner over the long term. The goal of the RUBIN study is to collect data on treatment, quality of life, and disease progression in patients with these conditions. Patients aged 18 and older with B-cell lymphomas are eligible to participate in this study. The study does not test new medications or forms of therapy.

Trial flow

Requirements

Diagnosis: 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) 

Age: 18–99 years

Line of therapy: Unabhängig von Therapielinie

Key inclusion criteria: Systemic therapy

Allocation

Randomisierung

Treatment

RegisterCollection of data regarding treatment choices and the quality of life in everyday care

Follow-up

60 months

Detailed description

B-cell lymphomas arise from a specific subgroup of white blood cells, the B lymphocytes. In B-cell lymphomas, these cells undergo malignant transformation, which can lead to the development of various forms of lymphoma. The most common B-cell lymphomas are diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL)—including small lymphocytic lymphoma (SLL)—and Burkitt lymphoma. A closely related disease is Waldenström’s disease (Waldenström macroglobulinemia, WM). Symptoms of these diseases include, among others, enlarged lymph nodes, fever, night sweats, and weight loss. The exact cause is unknown in most cases, but genetic mutations and infections may play a role.

There are various treatment options for the different types of B-cell lymphomas. The choice of treatment depends, among other factors, on the patient’s age and overall health, the presence of symptoms, the stage of the disease, and any prior treatments. However, there is often a lack of long-term data regarding treatment outcomes. Comparing the different treatments is further complicated by the fact that, in many cases, there is no standardized recording of interventions and outcomes.

The goal of the RUBIN study, as an observational study (registry), is to collect data on patients’ health status, prior treatments, current therapies, disease progression, and quality of life. This is intended to identify opportunities for improvement in routine care and to assess the success of new treatment methods in everyday clinical practice.

The study is purely observational, meaning that the choice of therapy is made independently of participation in the study. In addition, a decentralized biobank will be established to store blood or tissue samples for future research purposes (provided the patients consent). The study tracks the entire course of treatment for a maximum of approximately 5 years per patient.

Patients aged 18 and older with chronic lymphocytic leukemia (CLL), diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), or Waldenström macroglobulinemia (WM) are eligible to participate in this study.

Facts

  1. Which disease: Various forms of non-Hodgkin B-cell lymphomas (CLL, DLBCL, FL, MCL, MZL, WM)
  2. Cancer characteristics: Previously treated and previously untreated
  3. What the study investigates: Data collection regarding the course of treatment and the patients’ health status
  4. Study objective: To improve routine care and evaluate new treatment options in everyday clinical practice through long-term data collection
  5. Study duration: Follow-up for up to 5 years per patient
  6. Study characteristics: Observational study (registry); no new medications or therapies are being tested

Trial sites

10 trial sites in Germany are listed. Find a site near you.

  • Klinikum St. Marien Amberg

    Mariahilfbergweg 7, 92224 Amberg, Oberpfalz

    Recruiting
  • Universitätsklinikum Augsburg

    Stenglinstraße 2, 86156 Augsburg

    Recruiting
  • Caritas-Krankenhaus Bad Mergentheim

    Uhlandstraße 7, 97980 Bad Mergentheim

    Recruiting
  • Klinikum Coburg GmbH

    Ketschendorfer Straße 33, 96450 Coburg

    Recruiting
  • Universitätsklinikum Freiburg

    Hugstetter Straße 49, 79106 Freiburg

    Recruiting
  • Praxis für Interdisziplinäre Hämatologie und Onkologie

    Freiburg im Breisgau

    Recruiting

This list is compiled to the best of our knowledge but without guarantee: it may be incomplete, and a site's recruitment status can change at any time.

Medical editorial team

  • Dr. med. Sebastian SommerSpecialist in internal medicine with a focus on hematology and oncology
  • PD Dr. med. Matthias FröhlichSpecialist in internal medicine, immunology and emergency medicine

This description is based on the public trial registry (NCT06043011) and was translated into plain language by our medical editorial team. Whether participation is an option for you is a decision you make together with your treating physician.