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NCT Number: NCT06294652

AGMT Austrian Lymphoma Registry

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.

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Key information

Conditions

Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsklinik für Innere Medizin III, PMU Salzburg

Salzburg, State of Salzburg, 5020, Austria

Location status: Recruiting

Location contact

Richard Greil, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • There are no specific exclusion criteria.

Treatment and study plan

Primary outcomes

  1. General Characteristics

    Time frame: 10 years

    To describe general characteristics of lymphoma patients

  2. Genetic Profiling

    Time frame: 10 years

    To describe genetic risk profiles

  3. Proportion of lymphoma patients in Austria that require treatment

    Time frame: 10 years

    To describe the proportion of lymphoma patients in Austria that require treatment

  4. Proportion of lymphoma patients in Austria under active surveillance

    Time frame: 10 years

    To describe the proportion of lymphoma patients in Austria under active surveillance

  5. Number of patients with concomitant diseases

    Time frame: 10 years

    To describe concomitant diseases at diagnosis of lymphoma

  6. Number of treatment and outcome of treatment

    Time frame: 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

  7. Patient Outcome

    Time frame: 10 years

    To describe patient's outcome

  8. Toxicities

    Time frame: 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.)

Study contacts

Contact information is provided by the study sponsor or research team.

Daniela Wolkersdorfer, Dr.

CONTACT

[email protected]

+436626404412

Sponsors and collaborators

Lead sponsor

Arbeitsgemeinschaft medikamentoese Tumortherapie

Other

Registry information

Important dates

Study start
2024
Primary completion
2033
Study completion
2033
First posted
Mar 5, 2024
Registry last updated
Apr 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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