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

Chronic Lymphocytic Leukemia (CLL) Clinical Trial

— RUBIN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06043011
• Other study ID #: iOM-080485
• Status: Recruiting
• Start date: September 27, 2023
• Est. completion date: December 2033

Study information

• Verified date: October 2023
• Source: iOMEDICO AG
• Contact: Martina Jänicke, Dr.
• Phone: +4976115242
• Email: rubin[@]iomedico.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2950
• Est. completion date: December 2033
• Est. primary completion date: December 2033
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Other:
• Routine care as per site standard.
Physician's choice according to patient's needs.

Locations

Country	Name	City	State
Germany	Praxis für Interdisziplinäre Hämatologie und Onkologie	Freiburg

Sponsors (1)

Lead Sponsor	Collaborator
iOMEDICO AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Course of treatment (treatment reality)	Documentation of anamnestic data and therapy sequences. Documentation of anamnestic data and therapy sequences	5 years
Secondary	Best Response	Documentation of response rates per line of treatment.	5 years
Secondary	Progression-free survival	Documentation of progression-free survival per line of treatment.	5 years
Secondary	Overall survival	Documentation of overall survival time.	5 years
Secondary	Health-related quality of life (Patient-reported outcome)	EORTC QLQ-C30 core questionnaire	1 year
Secondary	Disease-specific quality of life (Patient-reported outcome, patients with CLL)	EORTC QLQ-CLL17	1 year
Secondary	Disease-specific quality of life (Patient-reported outcome, patients with LG-NHL)	EORTC QLQ-NHL-LG20	1 year
Secondary	Disease-specific quality of life (Patient-reported outcome, patients with HG-NHL)	EORTC QLQ-NHL-HG29	1 year