ClinicalTrials.gg
RecruitingNCT06043011RUBINUpdated Jul 13, 2026

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

An observational study in Chronic Lymphocytic Leukemia (CLL), Diffuse Large B-cell Lymphoma (DLBCL) and Follicular Lymphoma (FL), sponsored by iOMEDICO AG. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-13.

Sponsored by iOMEDICO AG · Observational

From the registry’s dates

  • Started Sep 2023; still recruiting 3 years 1 month later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,950
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • 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)
03

In context

Leukemia, Lymphocytic, Chronic, B-Cell

2,036 studies on the registry are indexed under Leukemia, Lymphocytic, Chronic, B-Cell; 237 are open to participants now.

This study's planned enrollment of 2,950 is above the median of 146 across 215 observational studies indexed under Leukemia, Lymphocytic, Chronic, B-Cell.

Browse Leukemia, Lymphocytic, Chronic, B-Cell studies →

Lead sponsor

iOMEDICO AG is the lead sponsor of 53 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Adult patients with hematologic malignancies requiring systemic treatment

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age ≥ 18 years
  • Confirmed diagnosis of the respective NHL
  • If patient is alive: signed written

    • For patients participating in the PRO survey: IC prior to or at day of start of respective .
    • For patients not participating in the PRO survey: IC latest eight weeks after start of respective line of treatment.

Exclusion criteria

Exclusion Criteria:

  • No systemic therapy for respective lymphoid .
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,950 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes

Groups and cohorts

  • Chronic Lymphocytic Leukemia (CLL)

    Patients with CLL receiving systemic treatment (physician's choice)

    Other: Routine care as per site standard.

  • Diffuse Large B-cell Lymphoma (DLBCL)

    Patients with DLBCL receiving systemic treatment (physician's choice)

    Other: Routine care as per site standard.

  • Follicular Lymphoma (FL)

    Patients with FL receiving systemic treatment (physician's choice)

    Other: Routine care as per site standard.

  • Mantle Cell Lymphoma (MCL)

    Patients with MCL receiving systemic treatment (physician's choice)

    Other: Routine care as per site standard.

  • Marginal Zone Lymphoma (MZL)

    Patients with MZL receiving systemic treatment (physician's choice)

    Other: Routine care as per site standard.

  • Waldenström's macroglobulinemia (WM)

    Patients with WM receiving systemic treatment (physician's choice)

    Other: Routine care as per site standard.

Interventions

  • OtherRoutine care as per site standard.

    Physician's choice according to patient's needs.

06

What researchers measure

Primary outcomes

  1. Course of treatment (treatment reality)

    Documentation of anamnestic data and therapy sequences. Documentation of anamnestic data and therapy sequences

    Time frame: 5 years

Secondary outcomes

  1. Best Response

    Documentation of response rates per line of treatment.

    Time frame: 5 years

  2. Progression-free survival

    Documentation of progression-free survival per line of treatment.

    Time frame: 5 years

  3. Overall survival

    Documentation of overall survival time.

    Time frame: 5 years

  4. Health-related quality of life (Patient-reported outcome)

    EORTC QLQ-C30 core questionnaire

    Time frame: 1 year

  5. Disease-specific quality of life (Patient-reported outcome, patients with CLL)

    EORTC QLQ-CLL17

    Time frame: 1 year

  6. Disease-specific quality of life (Patient-reported outcome, patients with LG-NHL)

    EORTC QLQ-NHL-LG20

    Time frame: 1 year

  7. Disease-specific quality of life (Patient-reported outcome, patients with HG-NHL)

    EORTC QLQ-NHL-HG29

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
  • Praxis für Interdisziplinäre Hämatologie und Onkologie
    Freiburg im Breisgau, Germany
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06043011
Lead sponsor
iOMEDICO AG
Responsible party
Sponsor
First posted
Sep 21, 2023
Start date
Sep 27, 2023
Primary completion
Dec 2033 (estimated)
Completion
Dec 2033 (estimated)
Last update
Jul 13, 2026

Study contacts

Martina Jänicke, Dr.
Contact
rubin@iomedico.com
+4976115242 ext. 0
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
Jens Kisro, Dr.
study chair · Lübecker Onkologische Schwerpunktpraxis, Germany
Patrick Marschner, Dr.
study chair · Praxis für Interdisziplinäre Hämatologie und Onkologie, Freiburg, Germany
Ingo Tamm, PD Dr.
study chair · Onkologische Schwerpunktpraxis Kurfürstendamm, Berlin, Germany
Robert Zeiser, Prof. Dr.
study chair · Universitätsklinikum Freiburg, Germany

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion