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Tumor Registry of Lymphatic Neoplasia (TLN-Registry)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00889798
Recruitment Status : Completed
First Posted : April 29, 2009
Last Update Posted : May 18, 2020
Sponsor:
Information provided by (Responsible Party):
iOMEDICO AG

Brief Summary:
The purpose of this registry is to record information on therapy reality of malignant lymphatic systemic diseases by office-based haematologists in Germany.

Condition or disease
Non-Hodgkin's Lymphoma (NHL) Chronic Lymphocytic Leukemia (CLL) Multiple Myeloma (MM)

Detailed Description:

The TLN is a prospective, longitudinal, nation wide cohort study with the purpose to record information on the antineoplastic treatment of lymphatic neoplasms in Germany. The registry will follow patients for up to five years. It will identify common therapeutic sequences and changes in the treatment of the disease. At inclusion, data in patient characteristics, comorbidities, tumor characteristics and previous treatments are collected. During the course of observation data on all systemic treatments, radiotherapies, surgeries, and outcome are documented.

The impact of nutrition (LyNut) and physical activity (LyNut) on the course of the adjuvant disease will be examined in patients with indolent and aggressive Non-Hodgin Lymphoma, as well as long-term effects of systemic treatment (LyTox) and quality of life (LyLife) in patients with multiple myeloma.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 3795 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Epidemiological Registry Describing Treatment Reality and Therapy Modalities of Patients With Malignant Lymphatic Systemic Diseases (Non-Hodgkin`s Lymphoma, Chronic Lymphocytic Leukemia and Multiple Myeloma) Requiring Therapy.
Study Start Date : April 2009
Actual Primary Completion Date : August 31, 2019
Actual Study Completion Date : August 31, 2019





Primary Outcome Measures :
  1. Course of treatment (treatment reality) [ Time Frame: 5 years per patient ]
    Documentation of anamnestic data and therapy sequences


Secondary Outcome Measures :
  1. Effectiveness of treatment [ Time Frame: 5 years per patient ]
    Documentation of response rates and progression-free survival per therapy sequence, overall survival time and adverse reactions



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with a malignant lymphatic disease requiring therapy
Criteria

Inclusion Criteria:

  • Confirmed diagnosis of Non-Hodgkin`s lymphoma, chronic lymphocytic leukaemia or multiple myeloma
  • Must receive a first- or second-line therapy
  • 18 years or older
  • Signed, written informed consent

Exclusion Criteria:

- no systemic therapy


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00889798


Sponsors and Collaborators
iOMEDICO AG
Investigators
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Study Chair: Wolfgang Knauf, MD Center for Haematology, Frankfurt, Germany
Study Chair: Wolfang Abenhardt, MD MVZ Onkologie im Elisenhof, München, Germany
Publications of Results:

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Responsible Party: iOMEDICO AG
ClinicalTrials.gov Identifier: NCT00889798    
Other Study ID Numbers: IOM-TLN
First Posted: April 29, 2009    Key Record Dates
Last Update Posted: May 18, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by iOMEDICO AG:
Malignant lymphatic disease
therapy-reality
observation
registry
therapy sequences
NHL
CLL
Germany
lenalidomide
alemtuzumab
rituximab
bendamustin
thalidomide
bortezomib
ibritumomab-tiuxetan
G-CSF (Granulocyte-Colony Stimulating Factor)
chronic lymphocytic leukaemia
follicular lymphoma
gastric MALT lymphoma (Mucosa Associated Lymphoid Tissue)
nongastric MALT lymphoma (Mucosa Associated Lymphoid Tissue)
nodal marginal zone lymphoma
splenic marginal zone lymphoma
mantle cell lymphoma
diffuse large b-cell lymphoma
Additional relevant MeSH terms:
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Lymphoma
Leukemia
Multiple Myeloma
Neoplasms, Plasma Cell
Lymphoma, Non-Hodgkin
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Leukemia, B-Cell