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

Sponsor

iOMEDICO AG (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06043011

Collaborator

(none)

2,950

Enrollment

123

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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)	Other: Routine care as per site standard.

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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

2950 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2033

Anticipated Study Completion Date :

Dec 1, 2033

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Course of treatment (treatment reality) [5 years]
Documentation of anamnestic data and therapy sequences. Documentation of anamnestic data and therapy sequences

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

iOMEDICO AG

Investigators

Study Chair: 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