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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00889798
Other study ID # IOM-TLN
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 2009
Est. completion date August 31, 2019

Study information

Verified date May 2020
Source iOMEDICO AG
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 3795
Est. completion date August 31, 2019
Est. primary completion date August 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
iOMEDICO AG

References & Publications (5)

Knauf W, Abenhardt W, Aldaoud A, Nusch A, Grugel R, Münz M, Hartmann H, Marschner N; TLN Study Group. Treatment of Non-transplant patients with multiple myeloma: routine treatment by office-based haematologists in Germany--data from the prospective Tumour — View Citation

Knauf W, Abenhardt W, Dörfel S, Meyer D, Grugel R, Münz M, Hartmann H, Marschner N. Routine treatment of patients with chronic lymphocytic leukaemia by office-based haematologists in Germany-data from the Prospective Tumour Registry Lymphatic Neoplasms. H — View Citation

Knauf W, Abenhardt W, Mohm J, Rauh J, Harde J, Kaiser-Osterhues A, Jänicke M, Marschner N; TLN-Group (Tumour Registry Lymphatic Neoplasms). Similar effectiveness of R-CHOP-14 and -21 in diffuse large B-cell lymphoma-data from the prospective German Tumour — View Citation

Knauf W, Abenhardt W, Slawik HR, Bückner U, Otremba B, Sauer A, Zahn MO, Wetzel N, Kaiser-Osterhues A, Houet L, Marschner N; TLN-Group (Tumour Registry Lymphatic Neoplasms). Rare lymphomas in routine practice-Treatment and outcome in Waldenström's macrogl — View Citation

Knauf W, Aldaoud A, Hutzschenreuter U, Klausmann M, Dille S, Wetzel N, Jänicke M, Marschner N; and the TLN-Group (Tumour Registry Lymphatic Neoplasms). Survival of non-transplant patients with multiple myeloma in routine care differs from that in clinical — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Course of treatment (treatment reality) Documentation of anamnestic data and therapy sequences 5 years per patient
Secondary Effectiveness of treatment Documentation of response rates and progression-free survival per therapy sequence, overall survival time and adverse reactions 5 years per patient
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