National registry for people with myelofibrosis and anemia in Germany.
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)
This project will collect health, treatment, and quality-of-life information from people in Germany with primary or secondary myelofibrosis and anemia to see how their care and symptoms change over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | iOMEDICO AG Industry-sponsored |
| Locations | 1 site (Multiple Locations) |
| Trial ID | NCT06976918 on ClinicalTrials.gov |
What this trial studies
RHODOLITE is a national, prospective, open-label, longitudinal, non-interventional multicenter registry that follows people with primary or secondary myelofibrosis and anemia in routine clinical care across Germany. Patients are enrolled when they start or continue systemic MF treatment and clinical data on patient characteristics, molecular diagnostics, comorbidities, treatment sequences, and outcomes are recorded. Health-related quality of life and other patient-reported outcomes are collected regularly for up to three years, with planned longer-term follow-up through the GSG‑MPN Bioregistry. The registry excludes patients planning allogeneic stem cell transplantation or actively enrolled in interventional trials and aims to map real-world treatment patterns and outcomes.
Who should consider this trial
Good fit: Adults in Germany with a confirmed diagnosis of primary or secondary (post-PV or post-ET) myelofibrosis who have anemia, are starting or receiving systemic MF treatment, can give informed consent, and are willing to complete patient-reported outcome questionnaires are ideal candidates.
Not a fit: Patients who are not receiving systemic therapy for MF, those planning immediate allogeneic stem cell transplantation, or those unable or unwilling to consent or complete PROs are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the registry could help clinicians identify treatment sequences and care strategies linked to better outcomes and quality of life for patients with myelofibrosis and anemia.
How similar studies have performed: This registry builds on established German MPN registry efforts such as the GSG‑MPN Bioregistry, and similar observational registries have successfully described real-world treatment patterns and outcomes in myeloproliferative neoplasms.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * No systemic therapy for diagnosed primary or secondary MF. * Planned allogenic stem cell transplantation (allo-SCT) or active participation in an interventional clinical trial.
Where this trial is running
Multiple Locations
- Multiple sites all over Germany — Multiple Locations, Germany (Recruiting)
Study contacts
- Study coordinator: iOMEDICO AG
- Email: info@iomedico.com
- Phone: +4976115242
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.