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

NCT06043011 | Recruiting

• 1 other identifier: iOM-080485
• Study Type: observational
• Target: 2,950
• Locations: 1 country
• Sites: 1

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.

Conditions

Marginal Zone Lymphoma (MZL); Waldenström's Macroglobulinemia (WM); Chronic Lymphocytic Leukemia (CLL); Diffuse Large B-cell Lymphoma (DLBCL); Follicular Lymphoma (FL); Mantle Cell Lymphoma (MCL)

Keywords

non-Hodgkin lymphoma (NHL)

Outcome Measures

Primary Outcomes (1)

• Course of treatment (treatment reality)

  Documentation of anamnestic data and therapy sequences. Documentation of anamnestic data and therapy sequences

  5 years

Secondary Outcomes (7)

• Best Response

  5 years

• Progression-free survival

  5 years

• Overall survival

  5 years

• Health-related quality of life (Patient-reported outcome)

  1 year

• Disease-specific quality of life (Patient-reported outcome, patients with CLL)

  1 year

Study Arms (6)

Chronic Lymphocytic Leukemia (CLL)

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

Other: Routine care as per site standard.

Diffuse Large B-cell Lymphoma (DLBCL)

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

Other: Routine care as per site standard.

Follicular Lymphoma (FL)

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

Other: Routine care as per site standard.

Mantle Cell Lymphoma (MCL)

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

Other: Routine care as per site standard.

Marginal Zone Lymphoma (MZL)

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

Other: Routine care as per site standard.

Waldenström's macroglobulinemia (WM)

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

Other: Routine care as per site standard.

Interventions

Routine care as per site standard. OTHER

Physician's choice according to patient's needs.

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients with hematologic malignancies requiring systemic treatment

You may qualify if:

• 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.

You may not qualify if:

• No systemic therapy for respective lymphoid malignancy.

Sponsors & Collaborators

• iOMEDICO AG: lead

Study Sites (1)

Praxis für Interdisziplinäre Hämatologie und Onkologie

Freiburg im Breisgau, Germany

RECRUITING

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Follicular; Lymphoma, Mantle-Cell; Lymphoma, B-Cell, Marginal Zone; Waldenstrom Macroglobulinemia; Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma, B-Cell; Lymphoma; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders

Study Officials

• Rainer Claus, Prof. Dr.

  Universitätsklinikum Augsburg, Germany

  STUDY CHAIR

• Tobias Dechow

  Studienzentrum Onkologie Ravensburg, Germany

  STUDY CHAIR

• Paul Graf La Rosée, Prof. Dr.

  Schwarzwald-Baar Klinikum, Germany

  STUDY CHAIR

• Jens Kisro, Dr.

  Lübecker Onkologische Schwerpunktpraxis, Germany

  STUDY CHAIR

• Patrick Marschner, Dr.

  Praxis für Interdisziplinäre Hämatologie und Onkologie, Freiburg, Germany

  STUDY CHAIR

• Ingo Tamm, PD Dr.

  Onkologische Schwerpunktpraxis Kurfürstendamm, Berlin, Germany

  STUDY CHAIR

• Robert Zeiser, Prof. Dr.

  Universitätsklinikum Freiburg, Germany

  STUDY CHAIR

Central Study Contacts

Martina Jänicke, Dr.

CONTACT

+4976115242; rubin@iomedico.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2023
• First Posted: September 21, 2023
• Study Start: September 27, 2023
• Primary Completion (Estimated): December 1, 2033
• Study Completion (Estimated): December 1, 2033
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)