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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by iOMEDICO AGThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Research Platform on Treatment, Quality of Life and Outcome of Patients With Hematologic Malignancies (RUBIN) - Extension of Tumor Registry Lymphatic Neoplasms
- ClinicalTrials.gov ID
- NCT06043011
- Acronym / sponsor ID
- RUBIN / iOM-080485
- 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)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,950 participants (estimated)
- Lead sponsor
- iOMEDICO AGIndustry (pharma, biotech, devices)
- Study start
- 27 Sep 2023 (actual)
- Primary completion
- Dec 2033 (estimated)
- Study completion
- Dec 2033 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Chronic Lymphocytic Leukemia (CLL) | – | Other: Routine care as per site standard.Patients with CLL receiving systemic treatment (physician's choice) |
| Diffuse Large B-cell Lymphoma (DLBCL) | – | Other: Routine care as per site standard.Patients with DLBCL receiving systemic treatment (physician's choice) |
| Follicular Lymphoma (FL) | – | Other: Routine care as per site standard.Patients with FL receiving systemic treatment (physician's choice) |
| Mantle Cell Lymphoma (MCL) | – | Other: Routine care as per site standard.Patients with MCL receiving systemic treatment (physician's choice) |
| Marginal Zone Lymphoma (MZL) | – | Other: Routine care as per site standard.Patients with MZL receiving systemic treatment (physician's choice) |
| Waldenström's macroglobulinemia (WM) | – | Other: Routine care as per site standard.Patients with WM receiving systemic treatment (physician's choice) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with hematologic malignancies requiring systemic treatment
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Confirmed diagnosis of the respective NHL
- If patient is alive: signed written informed consent
Key exclusion criteria (1 listed)
- No systemic therapy for respective lymphoid malignancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine care as per site standard.Physician's choice according to patient's needs. | Other | 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) |
Primary outcome
Course of treatment (treatment reality)
Time frame: 5 years
Documentation of anamnestic data and therapy sequences. Documentation of anamnestic data and therapy sequences
7 secondary outcomes
Best Response
Time frame: 5 years
Progression-free survival
Time frame: 5 years
Overall survival
Time frame: 5 years
Health-related quality of life (Patient-reported outcome)
Time frame: 1 year
Disease-specific quality of life (Patient-reported outcome, patients with CLL)
Time frame: 1 year
Disease-specific quality of life (Patient-reported outcome, patients with LG-NHL)
Time frame: 1 year
Disease-specific quality of life (Patient-reported outcome, patients with HG-NHL)
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rainer Claus, Prof. Dr. study chair
Universitätsklinikum Augsburg, Germany
Tobias Dechow study chair
Studienzentrum Onkologie Ravensburg, Germany
Paul Graf La Rosée, Prof. Dr. study chair
Schwarzwald-Baar Klinikum, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Lymphocytic Leukemia (CLL) and Diffuse Large B-cell Lymphoma (DLBCL), run by iOMEDICO AG at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martina Jänicke, Dr. (+4976115242 ext. 0, rubin@iomedico.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Course of treatment (treatment reality) (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.