AGMT Austrian Lymphoma Registry

April 9, 2025 updated by: Arbeitsgemeinschaft medikamentoese Tumortherapie

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.

Study Overview

Status

Recruiting

Conditions

Lymphoma

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 Type

Observational

Enrollment (Estimated)

4000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Daniela Wolkersdorfer, Dr.
Phone Number: +436626404412
Email: office@agmt.at

Study Locations

Austria
- - Salzburg, Austria, 5020
    - Recruiting
    - Universitätsklinik für Innere Medizin III, PMU Salzburg
    - Contact:
      
      Richard Greil, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Probability Sample

Study Population

Interested sites that treat patients in this indication will be invited to participate in this registry.

Description

Inclusion Criteria:

The registry will include patients ≥ 18 years with lymphoma.

Exclusion Criteria:

There are no specific exclusion criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
General Characteristics Time Frame: 10 years	To describe general characteristics of lymphoma patients	10 years
Genetic Profiling Time Frame: 10 years	To describe genetic risk profiles	10 years
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	10 years
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	10 years
Number of patients with concomitant diseases Time Frame: 10 years	To describe concomitant diseases at diagnosis of lymphoma	10 years
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	10 years
Patient Outcome Time Frame: 10 years	To describe patient's outcome	10 years
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.)	10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arbeitsgemeinschaft medikamentoese Tumortherapie

Investigators

Principal Investigator: Richard Greil, MD, Department of Internal Medicine III, Paracelsus Medical University Salzburg, Salzburg, Austria

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 27, 2024

Primary Completion (Estimated)

December 31, 2033

Study Completion (Estimated)

December 31, 2033

Study Registration Dates

First Submitted

February 28, 2024

First Submitted That Met QC Criteria

February 28, 2024

First Posted (Actual)

March 5, 2024

Study Record Updates

Last Update Posted (Actual)

April 10, 2025

Last Update Submitted That Met QC Criteria

April 9, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

AGMT_Lymphoma_Reg

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.