Non-Hodgkin's Lymphoma (NHL)TLN-RegistryNCT00889798
Tumor Registry of Lymphatic Neoplasia
An observational study of Non-Hodgkin's Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL), run by iOMEDICO AG.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkin's Lymphoma (NHL), Chronic Lymphocytic Leukemia (CLL), Multiple Myeloma (MM)
- How many people
- 3,795 participants
- Where
- No sites listed yet
- Study dates
- Apr 2009to 31 Aug 2019
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with a malignant lymphatic disease requiring therapy
Who may be able to join
- 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
Who cannot join
- no systemic therapy
About this study
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.
The purpose of this registry is to record information on therapy reality of malignant lymphatic systemic diseases by office-based haematologists in Germany.
Read the 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.
- 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)
- Medical subject headings
- Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, Chronic, B-Cell, Multiple Myeloma, Leukemia, B-Cell, Lymphoma, Follicular, Lymphoma, B-Cell, Marginal Zone, Lymphoma, Mantle-Cell, Lymphoma, Large B-Cell, Diffuse
What is being measured
The primary outcome is the main question the study is designed to answer.
Course of treatment (treatment reality)
Documentation of anamnestic data and therapy sequences
Measured: 5 years per patient
Secondary outcomes (1)
Effectiveness of treatment
Documentation of response rates and progression-free survival per therapy sequence, overall survival time and adverse reactions
Measured: 5 years per patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2009 (estimated)
- Study startApr 2009
- Primary completion31 Aug 2019
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Non-Hodgkin's Lymphoma (NHL)Studies of the same condition, open and under way.
- More trials run by iOMEDICO AGThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,795 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- iOMEDICO AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wolfgang Knauf, MD, Study chair, Center for Haematology, Frankfurt, GermanyWolfang Abenhardt, MD, Study chair, MVZ Onkologie im Elisenhof, München, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00889798
- Sponsor's protocol ID
- IOM-TLN
- Acronym
- TLN-Registry
- Status last verified
- May 2020
- First submitted
- 28 Apr 2009
- Last updated
- 18 May 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 24733536Knauf 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.
PubMed 25486127Knauf 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.
PubMed 30069704Knauf 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.
PubMed 31314918Knauf 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.
PubMed 32383192
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00889798
- Acronym / sponsor ID
- TLN-Registry / IOM-TLN
- Keywords
- Malignant lymphatic disease, therapy-reality, observation, registry, therapy sequences, NHL, CLL, Germany
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,795 participants (actual)
- Lead sponsor
- iOMEDICO AGIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 29 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with a malignant lymphatic disease requiring therapy
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- no systemic therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Course of treatment (treatment reality)
Time frame: 5 years per patient
Documentation of anamnestic data and therapy sequences
1 secondary outcome
Effectiveness of treatment
Time frame: 5 years per patient
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2020.
- Results publication: PubMed 24733536Knauf 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.
- Results publication: PubMed 25486127Knauf 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.
- Results publication: PubMed 30069704Knauf 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.
- Results publication: PubMed 31314918Knauf 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.
- Results publication: PubMed 32383192Knauf 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wolfgang Knauf, MD study chair
Center for Haematology, Frankfurt, Germany
Wolfang Abenhardt, MD study chair
MVZ Onkologie im Elisenhof, München, Germany
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Hodgkin's Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL), run by iOMEDICO AG.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Course of treatment (treatment reality) (time frame: 5 years per patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00889798, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2020.