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

Recruiting

• Conditions: Diffuse Large B-cell Lymphoma (DLBCL); Follicular Lymphoma (FL); Mantle Cell Lymphoma (MCL); Chronic Lymphocytic Leukemia (CLL); Marginal Zone Lymphoma (MZL); Waldenström's Macroglobulinemia (WM)
• Interventions: Other: Routine care as per site standard.

• Registration Number: NCT06043011
• Lead Sponsor: iOMEDICO AG

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.

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 Timeline

• Study First Submitted: 2023-09-01
• Study First Submitted QC: 2023-09-15
• Study First Posted: 2023-09-21
• Study Start: 2023-09-27
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-11
• Last Update Posted: 2024-10-14
• Primary Completion: 2033-12
• Study Completion: 2033-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2950

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Marginal Zone Lymphoma (MZL)	Routine care as per site standard.	Patients with MZL receiving systemic treatment (physician's choice)
Diffuse Large B-cell Lymphoma (DLBCL)	Routine care as per site standard.	Patients with DLBCL receiving systemic treatment (physician's choice)
Mantle Cell Lymphoma (MCL)	Routine care as per site standard.	Patients with MCL receiving systemic treatment (physician's choice)
Follicular Lymphoma (FL)	Routine care as per site standard.	Patients with FL receiving systemic treatment (physician's choice)
Waldenström's macroglobulinemia (WM)	Routine care as per site standard.	Patients with WM receiving systemic treatment (physician's choice)
Chronic Lymphocytic Leukemia (CLL)	Routine care as per site standard.	Patients with CLL receiving systemic treatment (physician's choice)

Primary Outcome Measures

Name	Time	Method
Course of treatment (treatment reality)	5 years	Documentation of anamnestic data and therapy sequences. Documentation of anamnestic data and therapy sequences

Secondary Outcome Measures

Name	Time	Method
Overall survival	5 years	Documentation of overall survival time.
Best Response	5 years	Documentation of response rates per line of treatment.
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
Progression-free survival	5 years	Documentation of progression-free survival per line of treatment.
Health-related quality of life (Patient-reported outcome)	1 year	EORTC QLQ-C30 core questionnaire

Trial Locations

Locations (1)

Praxis für Interdisziplinäre Hämatologie und Onkologie; 🇩🇪 Freiburg, Germany