AGMT Austrian Lymphoma Registry

Recruiting

• Conditions: Lymphoma

• Registration Number: NCT06294652
• Lead Sponsor: Arbeitsgemeinschaft medikamentoese Tumortherapie

Brief Summary

Lymphomas are a group of cancers that originate in the lymphatic system, a key component of the immune system. They can be broadly categorized into two main types: Hodgkin lymphoma (HL) and non-Hodgkin lymphoma (NHL).

There are different subtypes of HL, including classical Hodgkin lymphoma (cHL) and nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL). The subtypes of cHL include nodular sclerosis, mixed cellularity, lymphocyte-rich, and lymphocyte-depleted.

Non-Hodgkin lymphomas are more diverse and comprise a wide range of subtypes, each with distinct genetic, molecular, and clinical features. Common subtypes of NHL include Diffuse large B-cell lymphoma (DLBCL), Follicular lymphoma (FL), Mantle cell lymphoma (MCL), Chronic lymphocytic leukemia (CLL), myeloma, and other rarer subgroups.

Many of these diseases typically present with lymph node enlargement, bone marrow infiltration, general and lymphoma subtype specific symptoms and laboratory abnormalities.

Novel agents have improved the prognosis of high-risk lymphoma patients in the front-line and relapsed setting and more accurate prognostic tools enable less intensive treatment for low-risk patients, while maintaining their good prognosis.

Lymphoma disease have not been systematically assessed in Austria to date. This medical registry of the AGMT is thus the first Austrian-wide standardized documentation of epidemiology, clinical course and molecular and other biologic data of this disease. As lymphomas are a very heterogeneous group, not all subtypes will always be documented simultaneously in this registry. Which lymphoma subtype is to be documented can change over time, depending on which clinical question is currently in focus.

Detailed Description

This registry is designed as international multicenter observational cohort of patients with lymphoma. Information on patient´s clinical presentation, tests, diagnosis, and treatment will be obtained through extraction of data from existing patient medical charts. Longitudinal follow-up data, including survival and tumor progression, will also be extracted from patient medical charts. This patient follow-up data will be obtained until patient death or loss to follow-up.

For documentation in the registry, no further diagnostic or therapeutic measures are required than those already necessary in general. Participation in the registry must not interfere with treatment routines. Only routine data, which has already been recorded in the patient's medical chart, is transferred to the electronic Case Report Forms (eCRF). To maintain patient confidentiality, each patient will be assigned a unique patient identifying number upon enrollment; this number will accompany the patient's medical and other registry information throughout the lifetime of the registry.

A written consent must be obtained prior to the input of data. No informed consent is required from deceased patients.

Study Timeline

• Study Start: 2024-02-27
• Study First Submitted: 2024-02-28
• Study First Submitted QC: 2024-02-28
• Study First Posted: 2024-03-05
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-10
• Primary Completion: 2033-12-31
• Study Completion: 2033-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 4000

Inclusion Criteria

• The registry will include patients ≥ 18 years with lymphoma.

Exclusion Criteria

• There are no specific exclusion criteria.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
General Characteristics	10 years	To describe general characteristics of lymphoma patients
Patient Outcome	10 years	To describe patient's outcome
Proportion of lymphoma patients in Austria that require treatment	10 years	To describe the proportion of lymphoma patients in Austria that require treatment
Proportion of lymphoma patients in Austria under active surveillance	10 years	To describe the proportion of lymphoma patients in Austria under active surveillance
Number of patients with concomitant diseases	10 years	To describe concomitant diseases at diagnosis of lymphoma
Genetic Profiling	10 years	To describe genetic risk profiles
Toxicities	10 years	To describe toxicity with a focus on immunological mediated side effects of treatment (e.g. Cytokine release syndrome (CRS), Immune effector cell-associated neurotoxicity syndrome (ICAN) etc.)
Number of treatment and outcome of treatment	10 years	To describe treatment and outcome of treatment, among them; * historical standard with immunochemotherapy; * cellular therapies (e.g. Car-T cells); * novel immunotherapies such as bispecific antibodies; * continuous treatment or an induction/maintenance approach; * sequence of use of various treatments; * treatment duration; * treatment adjustments; * frequency and degree of response

Trial Locations

Locations (1)

Universitätsklinik für Innere Medizin III, PMU Salzburg; 🇦🇹 Salzburg, Austria