AGMT Austrian Lymphoma Registry

Lymphoma Clinical Trial

Official title:

AGMT Austrian Lymphoma Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06294652
• Other study ID #: AGMT_Lymphoma_Reg
• Status: Recruiting
• Start date: February 27, 2024
• Est. completion date: December 31, 2033

Study information

• Verified date: February 2024
• Source: Arbeitsgemeinschaft medikamentoese Tumortherapie
• Contact: Daniela Wolkersdorfer, Dr.
• Phone: +436626404412
• Email: office[@]agmt.at
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: December 31, 2033
• Est. primary completion date: December 31, 2033
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• There are no specific exclusion criteria.

Related Conditions & MeSH terms

• Lymphoma

Locations

Country	Name	City	State
Austria	Universitätsklinik für Innere Medizin III, PMU Salzburg	Salzburg

Sponsors (1)

Lead Sponsor	Collaborator
Arbeitsgemeinschaft medikamentoese Tumortherapie

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	General Characteristics	To describe general characteristics of lymphoma patients	10 years
Primary	Genetic Profiling	To describe genetic risk profiles	10 years
Primary	Proportion of lymphoma patients in Austria that require treatment	To describe the proportion of lymphoma patients in Austria that require treatment	10 years
Primary	Proportion of lymphoma patients in Austria under active surveillance	To describe the proportion of lymphoma patients in Austria under active surveillance	10 years
Primary	Number of patients with concomitant diseases	To describe concomitant diseases at diagnosis of lymphoma	10 years
Primary	Number of treatment and outcome of treatment	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
Primary	Patient Outcome	To describe patient's outcome	10 years
Primary	Toxicities	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