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

iOMEDICO

Status: Enrolling

Conditions: Marginal Zone Lymphoma (MZL); Follicular Lymphoma (FL); Mantle Cell Lymphoma (MCL); Diffuse Large B-cell Lymphoma (DLBCL); Chronic Lymphocytic Leukemia (CLL); Waldenström's Macroglobulinemia (WM)

Treatments: Other: Routine care as per site standard.

Study type: Observational

Funder types: Industry

Identifiers

NCT06043011

iOM-080485

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,950 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

2,950 participants in 6 patient groups

Chronic Lymphocytic Leukemia (CLL)

Description:

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

Treatment:

Other: Routine care as per site standard.

Diffuse Large B-cell Lymphoma (DLBCL)

Description:

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

Treatment:

Other: Routine care as per site standard.

Follicular Lymphoma (FL)

Description:

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

Treatment:

Other: Routine care as per site standard.

Mantle Cell Lymphoma (MCL)

Description:

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

Treatment:

Other: Routine care as per site standard.

Marginal Zone Lymphoma (MZL)

Description:

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

Treatment:

Other: Routine care as per site standard.

Waldenström's macroglobulinemia (WM)

Description:

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

Treatment:

Other: Routine care as per site standard.