BCR-ABL1-Negative Myeloid NeoplasmsNCT03125707
German MPN-Registry for BCR-ABL 1-Negative Myeloid Neoplasms (Study Group Ulm)
An observational study of BCR-ABL1-Negative Myeloid Neoplasms, run by University of Ulm at 30 sites in Germany.
Trial summary
To register a large number of patients with the diagnosis of a BCR-ABL 1- negative myeloid neoplasm (according to WHO 2008 / 2016 classification) in participating centers To store samples from all patients (e.g. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- BCR-ABL1-Negative Myeloid Neoplasms
- What is being tested?
- Registry study
- How many people
- 2,172 participants
- Where
- 30 sitesGermany
- Study dates
- May 2013to Sep 2045
- How long will I take part?
- 25 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 the diagnosis of a BCR-ABL 1-negative myeloid neoplasm in participating centers
Who may be able to join
- Both female and male patients meeting the mentioned inclusion criteria will be included in this registry, because the risk to get a myeloid neoplasm does not depend on a patient's gender. Patients must meet all of the following inclusion criteria to be eligible for enrollment into the registry:
- Patients with BCR-ABL 1-myeloid neoplasia according to WHO classification or IWG MRI criteria
- Age ≥ 18 years. There is no upper age limit.
- Signed written informed consent.
Who cannot join
- Severe neurological or psychiatric disorder interfering with ability to give an informed consent
- No consent for registration, storage and handling of the personal data
Trial locations and contacts
30 sites in 1 country. Contact the study team or a site near you to ask about taking part.
30 sites in 1 country
Germany30 sites, 27 recruiting
- Recruiting
Hämatologische Onkologie Praxis Augsburg
Augsburg, 86150
Markus Bangerter, MD, +498213446520, markus.bangerter@hop-augsburg.de
- Recruiting
Klinikum Augsburg
Augsburg, 86156
Klaus Hirschbühl, MD, +498214003715, klaus.hirschbuehl@klinikum-augsburg.de
- Recruiting
Helios Klinikum, Bad Saarow
Bad Saarow, 15526
Daniel Schöndube, MD, +493363173728, daniel.schoendube@helios-kliniken.de
- Recruiting
Klinikum Mittelbaden
Baden-Baden, 76532
Jutta Hagemeyer, MD, +497221/91-4126, j.hagemeyer@klinikum-mittelbaden.de
- Recruiting
MVZ Klinikum Coburg
Coburg, 96450
Christof Lamberti, MD, +49956122-34607, christof.lamberti@klinikum-coburg.de
- Recruiting
Donauwörth, Onko-Medeor
Donauwörth, 86609
Dirk Hempel, MD, +49906299939-0, donauwoerth@onko-medeor.de
- Recruiting
Onkologie, BAG, Dresden
Dresden, 01307
Thomas Illmer, MD, +493514400022, illmer@onkologie-dresden.de
- Recruiting
Onkologie Erding
Erding, 85435
Stefanie Jilg, MD, +49 8122 959139, stefanie.jilg@onkologie-erding.de
- Recruiting
Universitätsklinikum Freiburg
Freiburg im Breisgau, 79106
Cornelius Waller, MD, +497612700, cornelius.waller@uniklinik-freiburg.de
- Recruiting
Alb Fils Kliniken Göppingen
Göppingen, 73035
Martin Bommer, MD, +497161642962, martin.bommer@af-k.de
- Recruiting
Universitätsklinikum Greifswald
Greifswald, 17475
Florian Heidel, MD, +493834 - 86 22006, florian.heidel@med.uni-greifswald.de
- Withdrawn
Onkologische Praxis, Heidelberg
Heidelberg, 69115
- Withdrawn
Onkologische Schwerpunktpraxis, Heilbronn
Heilbronn, 74072
- Recruiting
Marienhospital Bochum-Herne
Herne, 44625
Dirk Strumberg, MD, +4923234991575, onkologie@marienhospital-herne.de
- Recruiting
Universitätsklinikum Jena
Jena, 07743
Andreas Hochhaus, MD, 03641 ext. 9324216, andreas.hochhaus@med.uni-jena.de
- Recruiting
Klinikum Kempten-Oberallgäu gGmbH
Kempten, 87439
Christian Langer, MD, +49831530 ext. 2245, christian.langer@klinikum-kempten.de
- Recruiting
Landshut VK&K Studien GbR
Landshut, 84036
Ana Hoffmann, MD, 087197403 ext. 429, ana.hoffmann@vehling-kaiser.de
- Active, not recruiting
Leer, Studienzentrum Unter Ems
Leer, 26789
- Recruiting
Universitätsklinikum Leipzig
Leipzig, 04103
Madlen Jentzsch, MD, +493419713061, madlen.jentzsch@medizin.uni-leipzig.de
- Recruiting
Universitätsklinikum Magdeburg
Magdeburg, 39120
Denise Wolleschak, MD, +4916713134, denise.wolleschak@med.ovgu.de
- Recruiting
Universitätsklinikum Mannheim
Mannheim, 55131
Andreas Reiter, MD, +496213830, andreas.reiter@umm.de
- Recruiting
Mannheim, Onkologiepraxis
Mannheim, 68161
Manfred Hensler, MD, +49621-22430, info@mannheimer-onkologie-praxis.de
- Recruiting
Memmingen, Onkologiepraxis
Memmingen, 87700
Juergen Jaeckle, MD, +498331 75049-00, jaeckle@onkologie-mm.de
- Recruiting
Mühlenkreiskliniken Minden
Minden, 32429
Martin Griesshammer, MD, +495717901184, martin.griesshammer@muehlenkreiskliniken.de
- Recruiting
Stauferklinikum Schwäbisch Gmünd
Mutlangen, 73557
Holger Hebart, MD, +4971717011397, holger.hebart@kliniken-ostalb.de
- Recruiting
Diakonie-Klinikum Stuttgart
Stuttgart, 70176
Jochen Greiner, MD, +497119913517, greiner@diak-stuttgart.de
- Recruiting
Stuttgart, MVZ am RBK
Stuttgart, 70376
Ulrike Schwinger, MD, 0711-8101-5983, ulrike.schwinger@rbk-mvz.de
- Recruiting
Universitätsklinikum Ulm
Ulm, 89081
Frank Stegelmann, MD, +49731500 ext. 45928, frank.stegelmann@uniklinik-ulm.de
- Recruiting
Rems-Murr-Kliniken Winnenden
Winnenden, 71334
Julia Glueck-Wolf, +49719559136031, julia.glueck-wolf@rems-murr-kliniken.de
- Recruiting
Würzburg / Kitzingen, Gemeinschaftspraxis Dr. Schlag
Würzburg, 97080
Bjoern Schoettker, MD, +49931322670, b.schoettker@onkopraxis-wuerzburg.de
About this study
To register a large number of patients with the diagnosis of a BCR-ABL 1- negative myeloid neoplasm (according to WHO 2008 / 2016 classification) in participating centers
To store samples from all patients (e.g. bone marrow aspirate, peripheral blood, plasma, and buccal swap, skin biopsy samples in exceptional cases)
To perform morphologic and genetic analyses
To assess clinical characteristics and outcome data using a defined catalogue containing clinically relevant variables
To assess biological disease features and correlate with clinical outcome data (prognostic and predictive markers)
To assess quality of life
Read the detailed description
To register a large number of patients with the diagnosis of a BCR-ABL 1- negative myeloid neoplasm (according to WHO 2008 / 2016 classification) in participating centers
To store samples from all patients (e.g. bone marrow aspirate, peripheral blood, plasma, and buccal swap, skin biopsy samples in exceptional cases)
To perform morphologic and genetic analyses
To assess clinical characteristics and outcome data using a defined catalogue containing clinically relevant variables
To assess biological disease features and correlate with clinical outcome data (prognostic and predictive markers)
To assess quality of life
- Conditions
- BCR-ABL1-Negative Myeloid Neoplasms
- Being tested
- Registry study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Registry studyOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment decision
Treatment decision (watch and wait, standard, investigational)
Measured: 25 years
Response
Response of treatment
Measured: 25 years
Overall survival
Survival over the whole study duration
Measured: 25 years
Progression-free-survival
Survival without any progression
Measured: 25 years
Duration of response
Duration of response over the whole study duration
Measured: 25 years
Quality of life assessed by the Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF Protocol 5/25/11, EORTC QLQ-C30, FACT-Lym (Fassung 4)), supplemented by information on self-assessed concomitant diseases and demographics.
Quality of life assessed by the Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF Protocol 5/25/11, EORTC QLQ-C30, FACT-Lym (Fassung 4)), supplemented by information on self-assessed concomitant diseases and demographics.
Measured: 25 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study startMay 2013
- Primary completionSep 2045 (estimated)
- Study completionSep 2045 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BCR-ABL1-Negative Myeloid NeoplasmsStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,172 participants (estimated)
- Target duration
- 25 Years
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frank Stegelmann, University of Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03125707
- Sponsor's protocol ID
- MPN Registry - Ulm
- Status last verified
- May 2023
- First submitted
- 11 Jan 2017
- Last updated
- 19 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- German MPN-Registry for BCR-ABL 1-Negative Myeloid Neoplasms (Study Group Ulm)
- ClinicalTrials.gov ID
- NCT03125707
- Acronym / sponsor ID
- MPN Registry - Ulm
- Conditions
- BCR-ABL1-Negative Myeloid Neoplasms
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,172 participants (estimated)
- Lead sponsor
- University of UlmUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Sep 2045 (estimated)
- Study completion
- Sep 2045 (estimated)
- First posted
- 24 Apr 2017 (actual)
- 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.
To register a large number of patients with the diagnosis of a BCR-ABL 1- negative myeloid neoplasm (according to WHO 2008 / 2016 classification) in participating centers
To store samples from all patients (e.g. bone marrow aspirate, peripheral blood, plasma, and buccal swap, skin biopsy samples in exceptional cases)
To perform morphologic and genetic analyses
To assess clinical characteristics and outcome data using a defined catalogue containing clinically relevant variables
To assess biological disease features and correlate with clinical outcome data (prognostic and predictive markers)
To assess quality of life
Detailed description
To register a large number of patients with the diagnosis of a BCR-ABL 1- negative myeloid neoplasm (according to WHO 2008 / 2016 classification) in participating centers
To store samples from all patients (e.g. bone marrow aspirate, peripheral blood, plasma, and buccal swap, skin biopsy samples in exceptional cases)
To perform morphologic and genetic analyses
To assess clinical characteristics and outcome data using a defined catalogue containing clinically relevant variables
To assess biological disease features and correlate with clinical outcome data (prognostic and predictive markers)
To assess quality of life
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 25 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with the diagnosis of a BCR-ABL 1-negative myeloid neoplasm in participating centers
Key inclusion criteria (4 listed)
- Both female and male patients meeting the mentioned inclusion criteria will be included in this registry, because the risk to get a myeloid neoplasm does not depend on a patient's gender. Patients must meet all of the following inclusion criteria to be eligible for enrollment into the registry:
- Patients with BCR-ABL 1-myeloid neoplasia according to WHO classification or IWG MRI criteria
- Age ≥ 18 years. There is no upper age limit.
- Signed written informed consent.
Key exclusion criteria (2 listed)
- Severe neurological or psychiatric disorder interfering with ability to give an informed consent
- No consent for registration, storage and handling of the personal data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Registry study | Other | – |
Primary outcome
Treatment decision
Time frame: 25 years
Treatment decision (watch and wait, standard, investigational)
Response
Time frame: 25 years
Response of treatment
Overall survival
Time frame: 25 years
Survival over the whole study duration
Progression-free-survival
Time frame: 25 years
Survival without any progression
Duration of response
Time frame: 25 years
Duration of response over the whole study duration
Quality of life assessed by the Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF Protocol 5/25/11, EORTC QLQ-C30, FACT-Lym (Fassung 4)), supplemented by information on self-assessed concomitant diseases and demographics.
Time frame: 25 years
Quality of life assessed by the Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF Protocol 5/25/11, EORTC QLQ-C30, FACT-Lym (Fassung 4)), supplemented by information on self-assessed concomitant diseases and demographics.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2023.
- Individual participant dataSharing planned: No
Related trials for BCR-ABL1-Negative Myeloid Neoplasms
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Azacitidine, Venetoclax, and Pevonedistat in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
Acute Myeloid Leukemia, Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative
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.
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of BCR-ABL1-Negative Myeloid Neoplasms, run by University of Ulm at 30 sites in Germany.
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 2 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: looking for participants now, as of the sponsor's last update on 19 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Frank Stegelmann, Dr. (+4973150045521, frank.stegelmann@uniklinik-ulm.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment decision (time frame: 25 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 May 2023; AzTrials last refreshed its copy on 6 Nov 2026.