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

ConditionsChronic Lymphocytic Leukemia (CLL)Diffuse Large B-cell Lymphoma (DLBCL)Follicular Lymphoma (FL)Mantle Cell Lymphoma (MCL)Marginal Zone Lymphoma (MZL)Waldenström's Macroglobulinemia (WM)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsoriOMEDICO AG

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

No systemic therapy for respective lymphoid malignancy.

Trial population

Adult patients with hematologic malignancies requiring systemic treatment

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Routine care as per site standard.

    Other intervention

    Physician's choice according to patient's needs.

Treatment groups

2,950 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Chronic Lymphocytic Leukemia (CLL)1 intervention
Group B: Diffuse Large B-cell Lymphoma (DLBCL)1 intervention
Group C: Follicular Lymphoma (FL)1 intervention
Group D: Mantle Cell Lymphoma (MCL)1 intervention
Group E: Marginal Zone Lymphoma (MZL)1 intervention
Group F: Waldenström's macroglobulinemia (WM)1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

iOMEDICO AG

Lead sponsor

Source ClinicalTrials.gov
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