Register of the German Lymphoma Alliance

Objectives of the GLA Register

Clinical studies can often only reflect certain aspects of the reality of care. In particular, rare constellations and underrepresented patient groups or patients with co-morbidities are often underrepresented.

The collection of “real-world data” is therefore an essential additional instrument for drawing conclusions about the course of therapy, prognosis and unmet medical needs from everyday data. Clinical registries represent the platform within which the above-mentioned data is quality controlled and can be collected taking into account methodological requirements.

The Lymphoma Register initiative within the GLA has set itself the task of setting up, operating and evaluating data for various lymphoma diseases. This involves integrating data from existing registers and creating opportunities to enter new data in a harmonized process.

Under the umbrella of the GLA-R, the existing registries have come together to grow into a common scientific exchange platform.

Inclusion criteria

If possible, all patients diagnosed with malignant lymphoma should be recorded, regardless of the line of treatment. (Hodgkin's lymphomas and CLL are recorded by appropriate registries).

Requirements are:

• Histological diagnosis of malignant lymphoma
• Patient age at inclusion ≥ 18 years
• Patient's consent to pass on his or her data

Patients are admitted regardless of the clinical stage of the disease and the therapy concept.

 

Exclusion criteria

The following exclusion criteria result from the points mentioned above:

• Patient age < 18 years
• Lack of consent from the patient to pass on their data
• lack of business or insight skills
• active therapy as part of a clinical study at inclusion

Documents

• Protocol (as of 11/2022)

Project coordination
Prof. Dr. Georg Hess, Dr. Anke Ohler
Mainz University Medical Center
III. Medical clinic and polyclinic
Langenbeckstr. 1

55131 Mainz
GLA-register@german-lymphoma-alliance.de

Background and rationale

Mantle cell lymphoma is a rare and often clinically aggressive B-cell lymphoma of the malignant non-Hodgkin lymphomas.

In particular, the comparatively small number of patients makes it difficult to carry out controlled clinical studies for all therapeutic situations and thus to develop a sufficient understanding of the disease progression in many patients.

In addition, the reality of therapy has changed significantly in recent years. The introduction and establishment of certain immunochemotherapies and the use of targeted therapies have contributed to this. However, the effects of these therapeutic changes have so far mainly been investigated in defined clinical studies and the effect in routine treatment remains to be seen.

The collection of real-world data is therefore particularly important in order to record treatment successes and to provide useful comparative data for future questions.

The aim of this registry is to prospectively and retrospectively document all patients with mantle cell lymphoma in a large number of participating European centers with regard to their epidemiological distribution and therapies. The registry is intended to contribute to a better understanding of the course of the disease and to develop future strategies to improve therapies.

In the future, we will also strive to link the data with biological test material.

 

Inclusion criteria

If possible, all patients diagnosed with mantle cell lymphoma should be recorded, regardless of the line of treatment. The only requirements are:

• Histologically confirmed mantle cell lymphoma
• Patient's consent to pass on his or her data
• Age of patients ≥ 18 years

Patients are admitted regardless of the clinical stage of the disease and the therapy concept.

Patients observed in a watch & wait strategy as well as patients in initial therapy or relapse therapy can be included.

 

Exclusion criteria

The following exclusion criteria result from the aforementioned inclusion criteria:

• Lymphoma other than mantle cell lymphoma
• Patient age < 18 years
• Lack of consent from the patient to pass on their data

Management of the register
Prof. Dr. med. Georg Hess
University Medicine of the Johannes Gutenberg University
Langenbeckstr.1
55131 Mainz

 

Project management
Dr. rer. nat. Anke Ohler
Telephone: +49 (0) 6131 17-7382
Fax: +49 (0) 6131 47-7382
Email: anke.ohler@unimedizin-mainz.de

Background and rationale

Just like MZoL, follicular lymphoma (FL) also belongs to the group of indolent B - non-Hodgkin's lymphomas and, in the advanced stage in which the vast majority of all patients are at diagnosis, cannot be cured with established therapies.

A wide variety of therapies are used in everyday clinical practice for FL. This is also reflected in the guidelines: the recommendations range from mild rituximab monotherapy to dose-intensive chemotherapy, followed by maintenance therapy.

In relapse, the therapeutic landscape is even more heterogeneous and there is no generally applicable standard therapy that can be recommended for all affected patients.

Due to the palliative situation of the patients and the fact that treatment is only given for lymphoma-associated symptoms, for example, and the diagnosis of FL does not automatically lead to therapy, diagnostics are not carried out uniformly outside of studies. As a result, there is little data on diagnosis and treatment in everyday clinical practice. In this situation, there is an urgent need for a prospective registry for follicular lymphoma in Germany, similar to the MZoL, which currently does not exist in this form. By expanding the marginal zone lymphoma registry to the FL, the project aims to make a significant contribution to health services research in FL in Germany.

 

Inclusion criteria

• Histologically proven follicular lymphoma confirmed by a reference pathologist
• Patient’s consent to pass on their data (based on the GDPR)
• Patient age ≥ 18 years

Inclusion takes place regardless of the clinical stage of the disease (localized vs. advanced) or the treating doctor's intended therapy concept: patients under watch & wait as well as patients in initial therapy or relapse therapy can be included.

 

Exclusion criteria

• The following exclusion criteria result from the points mentioned above:
• Patient age < 18 years
• Lack of consent from the patient to pass on their data
• lack of business or insight skills
• active therapy as part of a clinical study at inclusion

 

Documents

• FL cumulative recruitment GLA_March 2023

Management of the register
Prof. Dr. med. C. Buske
CCC Ulm
Albert-Einstein-Allee 11, 89081 Ulm

 

Project management
Ms. J. Gökeler
jacqueline.goekeler@uniklinik-ulm.de
T: 0731 500-65827
F: 0731 500-1265836

 

Office
Ms. Schmeller
sarah-anna.schmeller@uni-ulm.de
T: 0731 500-65888
F: 0731 500-65822

Background and rationale

Marginal zone lymphoma (MZoL) belongs to the group of indolent B non-Hodgkin lymphomas and is not curable with established therapies in the advanced stage, in which the vast majority of all patients are at diagnosis.

With MZoL, a wide variety of therapies are used in everyday clinical practice. This is also reflected in the guidelines: the recommendations range from mild rituximab monotherapy to chemotherapy.

In relapse, the therapeutic landscape is even more heterogeneous and there is no generally applicable standard therapy that can be recommended for all affected patients.

Due to the palliative situation of the patients and the fact that treatment is only given for lymphoma-associated symptoms, for example, and the diagnosis of MZoL does not automatically lead to therapy, diagnostics are not carried out uniformly outside of studies. As a result, there is little data on diagnosis and treatment in everyday clinical practice. In this situation, there is an urgent need for a prospective registry for marginal zone lymphoma in Germany. The project aims to make a significant contribution to health services research at the MZoL in Germany.

The aim of this registry study is to prospectively document all patients with marginal zone lymphoma in all participating centers in Germany with regard to their epidemiological distribution and treatment.

 

Inclusion criteria for inclusion in the registry

If possible, all patients diagnosed with MZoL should be recorded. The only requirements are:

• The histological diagnosis of MZoL must be made by a specialized hematopathologist or confirmed by reference pathology. This requirement serves to ensure quality in patient care.
• the patient's consent to pass on his or her data. Therefore, in the case of mental illnesses, there should be no doubts about the ability to do business or reason.
• an age of the patient ≥ 18 years

Admission takes place regardless of the clinical stage of the disease (localized versus advanced) or the treating doctor's intended therapeutic concept. There is no intervention in this regard within the framework of the register.

In order to expand the scope of experience, patients should also be included

• who are being treated in a therapy study (although no active study therapy at the time of inclusion). If the patient consents to participate in the registry, a copy of the primary study documentation is sufficient.
• with a recurrence of an MZoL after treatment before activation of the registry. This also applies if the relapse has progressed to an aggressive lymphoma.
• which are in a “watch & wait” status when the register is activated

Exclusion criteria

The following exclusion criteria result from the points mentioned above:

• Patient age < 18 years
• Lack of consent from the patient to pass on their data
• lack of business or insight skills
• active therapy as part of a clinical study at inclusion

Documents

• MZL cumulative recruitment GLA_March 2023

 

Management of the register
Prof. Dr. med. C. Buske
CCC Ulm
Albert-Einstein-Allee 11, 89081 Ulm

 

Project management
Ms. J. Gökeler
jacqueline.goekeler@uniklinik-ulm.de
T: 0731 500-65827
F: 0731 500-12 65836

Office
Ms. Schmeller
sarah-anna.schmeller@uni-ulm.de
T: 0731 500-65888
F: 0731 500-65822

Safety and effectiveness: R-EPOCH vs B-NHL protocol analogous to GMALL 2002

Case series

 

 

Management of the register

Prof. Dr. med. Kai Huebel
Cologne University Hospital
Clinic I for Internal Medicine
Kerpener Str. 62
50937 Cologne
Tel: +49221-478-86177
Fax: +49221-478-97230
Email: kai.huebel@uni-koeln.de

Background and rationale
Mature cell T-cell lymphomas (T-NHL) are a rare group of diseases that are often clinically aggressive and belong to the group of malignant non-Hodgkin lymphomas.

T-NHL are very heterogeneous with many subtypes that differ clinically and in terms of molecular background. This diversity of T-NHL and the small number of patients compared to other lymphomas make it difficult to carry out controlled clinical studies for all therapeutic situations. On the one hand, aspects of the therapy of T-NHL, such as: B. the use of radiation therapy has not been tested in controlled clinical studies, but is carried out in analogy to the treatment of B-cell lymphomas. On the other hand, this makes it difficult to adequately understand the influence of different therapies on the individual subtypes and their disease progression. Little is known about the treatment practice of T-NHL in Germany.

In recent years, many new therapeutic concepts have been developed based on a better understanding of the molecular mechanisms of T-NHL. Due to the above-mentioned heterogeneity and rarity of T-NHL, its implementation in controlled clinical studies worldwide is only hesitant.

 

The collection of “real word data” is therefore of great importance in order to reflect the reality of treatment in Germany, to generate information about the value of therapy concepts and to provide a basis for future clinical studies. The T-NHL Register would like to make a contribution to healthcare research at T-NHL in Germany and serve as a platform for future studies.

The aim of the T-NHL registry is to prospectively and retrospectively document the epidemiological and clinical data of patients with T-NHL in all participating centers in Germany. In addition, biological materials are stored in a database in order to be able to link clinical and molecular data in future analyses.

 

Inclusion criteria

If possible, all patients diagnosed with T-NHL should be recorded, regardless of the treatment line. Requirements are:

• Histological diagnosis of mature cell nodal or extranodal T-NHL (except primary cutaneous T-NHL)
• Patient age at inclusion ≥ 18 years
• Patient's consent to pass on his or her data

Patients are admitted regardless of the clinical stage of the disease and the therapy concept.

Exclusion criteria

The following exclusion criteria result from the aforementioned inclusion criteria:

• Primary cutaneous T-NHL
• Patient age at inclusion < 18 years
• Lack of consent from the patient to pass on their data

 

Management of the register

PD Dr. med. Thomas Weber
University Hospital Halle (Saale)
Serious. Pit. Street 40
06120 Halle (Saale)

 

Prof. Dr. med. Gerald Wulf
Göttingen University Medical Center
Robert-Koch-Str. 40
37075 Göttingen

 

Project management

Sabine Edemir
Telephone: +49 (0) 345 557-3170
Fax: +49 (0) 345 557-
Email: tnhl.register@uk-halle.de

Non-interventional, prospective registry study on the treatment practice of PTLD in clinical routine (Germany 2006-2012)

 

Sponsor
University Medicine Berlin Augustenburger Platz 1 D-13353 Berlin

 

Head of clinical trial (LKP)
Prof. Dr. med. Ralf Ulrich Trappe

 

 

Management of the register

Prof. Dr. med. Ralf Ulrich Trappe
DIAKO Ev. Diakonie-Krankenhaus non-profit GmbH

Gröpelinger Heerstr. 406-408

28239 Bremen