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

NCT ID: NCT06043011

Last Updated: 2026-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2950 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-27

Study Completion Date

2033-12-31

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.

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)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Chronic Lymphocytic Leukemia (CLL)

Patients with CLL receiving systemic treatment (physician's choice)

Routine care as per site standard.

Intervention Type OTHER

Physician's choice according to patient's needs.

Diffuse Large B-cell Lymphoma (DLBCL)

Patients with DLBCL receiving systemic treatment (physician's choice)

Routine care as per site standard.

Intervention Type OTHER

Physician's choice according to patient's needs.

Follicular Lymphoma (FL)

Patients with FL receiving systemic treatment (physician's choice)

Routine care as per site standard.

Intervention Type OTHER

Physician's choice according to patient's needs.

Mantle Cell Lymphoma (MCL)

Patients with MCL receiving systemic treatment (physician's choice)

Routine care as per site standard.

Intervention Type OTHER

Physician's choice according to patient's needs.

Marginal Zone Lymphoma (MZL)

Patients with MZL receiving systemic treatment (physician's choice)

Routine care as per site standard.

Intervention Type OTHER

Physician's choice according to patient's needs.

Waldenström's macroglobulinemia (WM)

Patients with WM receiving systemic treatment (physician's choice)

Routine care as per site standard.

Intervention Type OTHER

Physician's choice according to patient's needs.

Interventions

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Routine care as per site standard.

Physician's choice according to patient's needs.

Intervention Type OTHER

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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iOMEDICO AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rainer Claus, Prof. Dr.

Role: STUDY_CHAIR

Universitätsklinikum Augsburg, Germany

Tobias Dechow

Role: STUDY_CHAIR

Studienzentrum Onkologie Ravensburg, Germany

Paul Graf La Rosée, Prof. Dr.

Role: STUDY_CHAIR

Schwarzwald-Baar Klinikum, Germany

Jens Kisro, Dr.

Role: STUDY_CHAIR

Lübecker Onkologische Schwerpunktpraxis, Germany

Patrick Marschner, Dr.

Role: STUDY_CHAIR

Praxis für Interdisziplinäre Hämatologie und Onkologie, Freiburg, Germany

Ingo Tamm, PD Dr.

Role: STUDY_CHAIR

Onkologische Schwerpunktpraxis Kurfürstendamm, Berlin, Germany

Robert Zeiser, Prof. Dr.

Role: STUDY_CHAIR

Universitätsklinikum Freiburg, Germany

Locations

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Praxis für Interdisziplinäre Hämatologie und Onkologie

Freiburg im Breisgau, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Martina Jänicke, Dr.

Role: CONTACT

+4976115242 ext. 0

Other Identifiers

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iOM-080485

Identifier Type: -

Identifier Source: org_study_id

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