Chronic Lymphocytic Leukemia (CLL)RUBINNCT06043011
Registry Platform Hematologic Malignancies (RUBIN) - Extension of Tumor Registry Lymphatic Neoplasms
An observational study of Chronic Lymphocytic Leukemia (CLL) and Diffuse Large B-cell Lymphoma (DLBCL), run by iOMEDICO AG at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia (CLL), Diffuse Large B-cell Lymphoma (DLBCL), Follicular Lymphoma (FL)
- What is being tested?
- Routine care as per site standard.
- How many people
- 2,950 participants
- Where
- 1 siteGermany
- Study dates
- 27 Sep 2023to Dec 2033
- How long will I take part?
- 5 Years
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with hematologic malignancies requiring systemic treatment
Who may be able to join
- 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.
Who cannot join
- No systemic therapy for respective lymphoid malignancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Praxis für Interdisziplinäre Hämatologie und Onkologie
Freiburg im Breisgau
About this study
Official title: Clinical Research Platform on Treatment, Quality of Life and Outcome of Patients With Hematologic Malignancies (RUBIN) - Extension of Tumor Registry Lymphatic Neoplasms
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.
Read the 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.
- 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)
- Being tested
- Routine care as per site standard.
- Keywords
- non-Hodgkin lymphoma (NHL)
- Medical subject headings
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine care as per site standard.Other
Physician's choice according to patient's needs.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Lymphocytic Leukemia (CLL) | Patients with CLL receiving systemic treatment (physician's choice) Receives: Other: Routine care as per site standard. | |
| Diffuse Large B-cell Lymphoma (DLBCL) | Patients with DLBCL receiving systemic treatment (physician's choice) Receives: Other: Routine care as per site standard. | |
| Follicular Lymphoma (FL) | Patients with FL receiving systemic treatment (physician's choice) Receives: Other: Routine care as per site standard. | |
| Mantle Cell Lymphoma (MCL) | Patients with MCL receiving systemic treatment (physician's choice) Receives: Other: Routine care as per site standard. | |
| Marginal Zone Lymphoma (MZL) | Patients with MZL receiving systemic treatment (physician's choice) Receives: Other: Routine care as per site standard. | |
| Waldenström's macroglobulinemia (WM) | Patients with WM receiving systemic treatment (physician's choice) Receives: Other: Routine care as per site standard. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Course of treatment (treatment reality)
Documentation of anamnestic data and therapy sequences. Documentation of anamnestic data and therapy sequences
Measured: 5 years
Secondary outcomes (7)
Best Response
Documentation of response rates per line of treatment.
Measured: 5 years
Progression-free survival
Documentation of progression-free survival per line of treatment.
Measured: 5 years
Overall survival
Documentation of overall survival time.
Measured: 5 years
Health-related quality of life (Patient-reported outcome)
EORTC QLQ-C30 core questionnaire
Measured: 1 year
Disease-specific quality of life (Patient-reported outcome, patients with CLL)
EORTC QLQ-CLL17
Measured: 1 year
Disease-specific quality of life (Patient-reported outcome, patients with LG-NHL)
EORTC QLQ-NHL-LG20
Measured: 1 year
Disease-specific quality of life (Patient-reported outcome, patients with HG-NHL)
EORTC QLQ-NHL-HG29
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start27 Sep 2023
- Primary completionDec 2033 (estimated)
- Study completionDec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic Leukemia (CLL)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,950 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- iOMEDICO AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rainer Claus, Prof. Dr., Study chair, Universitätsklinikum Augsburg, GermanyTobias Dechow, Study chair, Studienzentrum Onkologie Ravensburg, GermanyPaul Graf La Rosée, Prof. Dr., Study chair, Schwarzwald-Baar Klinikum, GermanyJens Kisro, Dr., Study chair, Lübecker Onkologische Schwerpunktpraxis, GermanyPatrick Marschner, Dr., Study chair, Praxis für Interdisziplinäre Hämatologie und Onkologie, Freiburg, GermanyIngo Tamm, PD Dr., Study chair, Onkologische Schwerpunktpraxis Kurfürstendamm, Berlin, GermanyRobert Zeiser, Prof. Dr., Study chair, Universitätsklinikum Freiburg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06043011
- Sponsor's protocol ID
- iOM-080485
- Acronym
- RUBIN
- Status last verified
- Jul 2026
- First submitted
- 1 Sep 2023
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No