Clinical trial NCT00889798: Tumor Registry of Lymphatic Neoplasia
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Hodgkin's Lymphoma (NHL)
Chronic Lymphocytic Leukemia (CLL)
Multiple Myeloma (MM)
Keywords: 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
Lead sponsor: iOMEDICO AG
Sponsor class: INDUSTRY
First posted: 2009-04-29
Enrollment: 3795
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with a malignant lymphatic disease requiring therapy

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.

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.

Eligibility 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

Primary outcomes:
measure: Course of treatment (treatment reality)
timeFrame: 5 years per patient
Secondary outcomes:
measure: Effectiveness of treatment
timeFrame: 5 years per patient
Other outcomes:
Locations:
Study officials:
affiliation: Center for Haematology, Frankfurt, Germany
name: Wolfgang Knauf, MD
role: STUDY_CHAIR
affiliation: MVZ Onkologie im Elisenhof, München, Germany
name: Wolfang Abenhardt, MD
role: STUDY_CHAIR
References:
citation: Knauf W, Abenhardt W, Dorfel S, Meyer D, Grugel R, Munz 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. Hematol Oncol. 2015 Mar;33(1):15-22. doi: 10.1002/hon.2139. Epub 2014 Apr 15.
citation: Knauf W, Abenhardt W, Aldaoud A, Nusch A, Grugel R, Munz 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 Registry Lymphatic Neoplasms (TLN). Oncol Res Treat. 2014;37(11):635-6, 638-44. doi: 10.1159/000368315. Epub 2014 Oct 17.
citation: Knauf W, Aldaoud A, Hutzschenreuter U, Klausmann M, Dille S, Wetzel N, Janicke 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 trials-data from the prospective German Tumour Registry Lymphatic Neoplasms. Ann Hematol. 2018 Dec;97(12):2437-2445. doi: 10.1007/s00277-018-3449-8. Epub 2018 Aug 1.
citation: Knauf W, Abenhardt W, Mohm J, Rauh J, Harde J, Kaiser-Osterhues A, Janicke 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 Registry Lymphatic Neoplasms. Eur J Haematol. 2019 Nov;103(5):460-471. doi: 10.1111/ejh.13295. Epub 2019 Sep 4.
citation: Knauf W, Abenhardt W, Slawik HR, Buckner 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 Waldenstrom's macroglobulinaemia in the prospective German Tumour Registry Lymphatic Neoplasms. Hematol Oncol. 2020 Aug;38(3):344-352. doi: 10.1002/hon.2740. Epub 2020 May 8.