Status:
NOT_YET_RECRUITING
Registry Platform Myelofibrosis and Anemia
Lead Sponsor:
iOMEDICO AG
Collaborating Sponsors:
German Study Group for Myeloproliferative Neoplasms (GSG-MPN)
Conditions:
Primary Myelofibrosis
Secondary Myelofibrosis
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of the project is to set up a national, prospective, longitudinal, multicenter cohort study, a tumor registry platform, to document uniform data on characteristics, molecular diagnostics, ...
Detailed Description
RHODOLITE is a national, prospective, open-label, longitudinal, non-interventional multicenter cohort study (tumour registry platform) to describe treatment in routine clinical practice of myelofibros...
Eligibility Criteria
Inclusion
- 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
- No systemic therapy for diagnosed primary or secondary MF.
- Planned allogenic stem cell transplantation (allo-SCT) or active participation in an interventional clinical trial.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2031
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06976918
Start Date
September 1 2025
End Date
September 1 2031
Last Update
May 16 2025
Active Locations (1)
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1
Multiple sites all over Germany
Multiple Locations, Germany