Clinical trial NCT06043011: Registry Platform Hematologic Malignancies (RUBIN) - Extension of Tumor Registry Lymphatic Neoplasms
Official title: Clinical Research Platform on Treatment, Quality of Life and Outcome of Patients With Hematologic Malignancies (RUBIN) - Extension of Tumor Registry Lymphatic Neoplasms
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: 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)
Keywords: non-Hodgkin lymphoma (NHL)
Lead sponsor: iOMEDICO AG
Sponsor class: INDUSTRY
First posted: 2023-09-21
Enrollment: 2950
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients with hematologic malignancies requiring systemic treatment

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Course of treatment (treatment reality)
timeFrame: 5 years
Secondary outcomes:
measure: Best Response
timeFrame: 5 years
measure: Progression-free survival
timeFrame: 5 years
measure: Overall survival
timeFrame: 5 years
measure: Health-related quality of life (Patient-reported outcome)
timeFrame: 1 year
measure: Disease-specific quality of life (Patient-reported outcome, patients with CLL)
timeFrame: 1 year
measure: Disease-specific quality of life (Patient-reported outcome, patients with LG-NHL)
timeFrame: 1 year
measure: Disease-specific quality of life (Patient-reported outcome, patients with HG-NHL)
timeFrame: 1 year
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: Praxis für Interdisziplinäre Hämatologie und Onkologie
Study officials:
affiliation: Universitätsklinikum Augsburg, Germany
name: Rainer Claus, Prof. Dr.
role: STUDY_CHAIR
affiliation: Studienzentrum Onkologie Ravensburg, Germany
name: Tobias Dechow
role: STUDY_CHAIR
affiliation: Schwarzwald-Baar Klinikum, Germany
name: Paul Graf La Rosée, Prof. Dr.
role: STUDY_CHAIR
affiliation: Lübecker Onkologische Schwerpunktpraxis, Germany
name: Jens Kisro, Dr.
role: STUDY_CHAIR
affiliation: Praxis für Interdisziplinäre Hämatologie und Onkologie, Freiburg, Germany
name: Patrick Marschner, Dr.
role: STUDY_CHAIR
affiliation: Onkologische Schwerpunktpraxis Kurfürstendamm, Berlin, Germany
name: Ingo Tamm, PD Dr.
role: STUDY_CHAIR
affiliation: Universitätsklinikum Freiburg, Germany
name: Robert Zeiser, Prof. Dr.
role: STUDY_CHAIR
References: