Primary MyelofibrosisRHODOLITENCT06976918
Research Platform Myelofibrosis and Anemia
An observational study of Primary Myelofibrosis and Secondary Myelofibrosis, run by iOMEDICO AG at 1 site in Germany.
Trial summary
The purpose of the project is to set up a national, prospective, longitudinal, multicenter cohort study, a tumor research platform, to document uniform data on characteristics, molecular diagnostics, treatment and course of disease and to collect patient-reported outcomes for patients with primary and secondary… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Myelofibrosis, Secondary Myelofibrosis, Post-polycythemia Vera Myelofibrosis
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- 19 Feb 2026to Sep 2031
- 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: Adult patients with primary myelofibrosis or post-polycythemia vera or post-essential thrombocythemia myelofibrosis (MF) with anemia
Who may be able to join
- Confirmed diagnosis of primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF) (Note: diagnosis according to WHO-2017, ICC-2022 or WHO-2022 or IWG-MRT criteria, respectively).
- Diagnosis of anemia at the time of enrollment as per individual, clinical assessment by the local physician.
- Start of first or subsequent systemic treatment for MF.
- Informed consent and registration for the GSG-MPN Bioregistry.
- Willingness and capability to participate in PRO assessment.
- Signed and dated informed consent form for RHODOLITE at the latest six weeks after start of the respective systemic MF treatment.
Who cannot join
- No systemic therapy for diagnosed primary or secondary MF.
- Planned allogenic stem cell transplantation (allo-SCT) or active participation in an interventional clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Multiple sites all over Germany
Multiple Locations
iOMEDICO AG, +49 761 152420, info@iomedico.com
About this study
Official title: Clinical Research Platform on Treatment, Quality of Life and Outcome of Patients With Primary and Secondary Myelofibrosis and Anemia Who Are JAK Inhibitor Treatment-naïve or JAK Inhibitor Treatment-experienced (RHODOLITE)
The purpose of the project is to set up a national, prospective, longitudinal, multicenter cohort study, a tumor research platform, to document uniform data on characteristics, molecular diagnostics, treatment and course of disease and to collect patient-reported outcomes for patients with primary and secondary myelofibrosis and anemia in Germany.
Read the detailed description
RHODOLITE is a national, prospective, open-label, longitudinal, non-interventional multicenter cohort study (research platform) to describe treatment in routine clinical practice of myelofibrosis patients in routine care in Germany.
RHODOLITE will follow patients for up to three years with the aim to 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 and outcome are documented.
Health-related quality of life (HRQoL) will be evaluated for up to three years.
The RHODOLITE project is a joint project with the German Study Group for Myeloproliferative Neoplasms (GSG-MPN) and its GSG-MPN Bioregistry (NCT03125707). Details on treatment and outcome will be collected in RHODOLITE for up to three years, while long-term follow-up for a minimum of additional five years will be performed in the GSG-MPN Bioregistry.
- Conditions
- Primary Myelofibrosis, Secondary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis, Anemia, Myelofibrosis; Anemia
- Medical subject headings
- Primary Myelofibrosis, Anemia
What is being measured
The primary outcome is the main question the study is designed to answer.
Documentation of systemic treatment for MF and therapy sequences
Types and frequencies of systemic treatment for MF during observation time.
Measured: 3 years per patient
Secondary outcomes (7)
Hematologic response
Frequencies of hematologic response (improved, stable, worsened) per line of treatment
Measured: 3 years per patient
Splenic response
Frequencies of splenic response (improved, stable, worsened) per line of treatment
Measured: 3 years per patient
Overall response rate (ORR)
Documentation of ORR per line of treatment
Measured: 3 years per patient
Progression free survival (PFS)
Documentation of PFS per line of treatment
Measured: 3 years per patient
Overall survival
Documentation of OS per line of treatment
Measured: 3 years per patient
Health-related quality of life (Patient-reported outcome, PRO)
European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (EORTC QLQ-C30, the lower the score the better the QoL)
Measured: 3 years per patient
Assessment of Myelofibrosis-related symptoms
Myelofibrosis Symptom Assessment form (MFSAF) questionnaire 7-day Recall
Measured: 3 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 posted16 May 2025
- Study start19 Feb 2026
- Primary completionSep 2031 (estimated)
- Study completionSep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary MyelofibrosisStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- iOMEDICO AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- German Study Group for Myeloproliferative Neoplasms (GSG-MPN)
- Responsible party
- Sponsor
- Investigators
- Konstanze Döhner, Prof. Dr. med., Study chair, University Hospital Ulm, GermanySteffen Koschmieder, Prof. Dr. med., Study chair, University Hospital Aachen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06976918
- Sponsor's protocol ID
- iOM-110507
- Acronym
- RHODOLITE
- Status last verified
- Mar 2026
- First submitted
- 29 Apr 2025
- Last updated
- 5 Jun 2026
- 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 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Research Platform on Treatment, Quality of Life and Outcome of Patients With Primary and Secondary Myelofibrosis and Anemia Who Are JAK Inhibitor Treatment-naïve or JAK Inhibitor Treatment-experienced (RHODOLITE)
- ClinicalTrials.gov ID
- NCT06976918
- Acronym / sponsor ID
- RHODOLITE / iOM-110507
- Conditions
- Primary Myelofibrosis, Secondary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis, Anemia, Myelofibrosis; Anemia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- iOMEDICO AGIndustry (pharma, biotech, devices)
- Collaborators
- German Study Group for Myeloproliferative Neoplasms (GSG-MPN)
- Study start
- 19 Feb 2026 (actual)
- Primary completion
- Sep 2031 (estimated)
- Study completion
- Sep 2031 (estimated)
- First posted
- 16 May 2025 (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.
The purpose of the project is to set up a national, prospective, longitudinal, multicenter cohort study, a tumor research platform, to document uniform data on characteristics, molecular diagnostics, treatment and course of disease and to collect patient-reported outcomes for patients with primary and secondary myelofibrosis and anemia in Germany.
Detailed description
RHODOLITE is a national, prospective, open-label, longitudinal, non-interventional multicenter cohort study (research platform) to describe treatment in routine clinical practice of myelofibrosis patients in routine care in Germany.
RHODOLITE will follow patients for up to three years with the aim to 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 and outcome are documented.
Health-related quality of life (HRQoL) will be evaluated for up to three years.
The RHODOLITE project is a joint project with the German Study Group for Myeloproliferative Neoplasms (GSG-MPN) and its GSG-MPN Bioregistry (NCT03125707). Details on treatment and outcome will be collected in RHODOLITE for up to three years, while long-term follow-up for a minimum of additional five years will be performed in the GSG-MPN Bioregistry.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with primary myelofibrosis or post-polycythemia vera or post-essential thrombocythemia myelofibrosis (MF) with anemia
Key inclusion criteria (6 listed)
- Confirmed diagnosis of primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF) (Note: diagnosis according to WHO-2017, ICC-2022 or WHO-2022 or IWG-MRT criteria, respectively).
- Diagnosis of anemia at the time of enrollment as per individual, clinical assessment by the local physician.
- Start of first or subsequent systemic treatment for MF.
- Informed consent and registration for the GSG-MPN Bioregistry.
- Willingness and capability to participate in PRO assessment.
Key exclusion criteria (2 listed)
- No systemic therapy for diagnosed primary or secondary MF.
- Planned allogenic stem cell transplantation (allo-SCT) or active participation in an interventional clinical trial.
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
Documentation of systemic treatment for MF and therapy sequences
Time frame: 3 years per patient
Types and frequencies of systemic treatment for MF during observation time.
7 secondary outcomes
Hematologic response
Time frame: 3 years per patient
Splenic response
Time frame: 3 years per patient
Overall response rate (ORR)
Time frame: 3 years per patient
Progression free survival (PFS)
Time frame: 3 years per patient
Overall survival
Time frame: 3 years per patient
Health-related quality of life (Patient-reported outcome, PRO)
Time frame: 3 years per patient
Assessment of Myelofibrosis-related symptoms
Time frame: 3 years per patient
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 5 Jun 2026.
- 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.
Konstanze Döhner, Prof. Dr. med. study chair
University Hospital Ulm, Germany
Steffen Koschmieder, Prof. Dr. med. study chair
University Hospital Aachen, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Myelofibrosis and Secondary Myelofibrosis, run by iOMEDICO AG at 1 site 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 6 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 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 iOMEDICO AG (+4976115242 ext. 0, info@iomedico.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Documentation of systemic treatment for MF and therapy sequences (time frame: 3 years per patient). 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 5 Jun 2026.