Trials / Recruiting
RecruitingNCT06976918
Registry Platform Myelofibrosis and Anemia
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)
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 200 (estimated)
- Sponsor
- iOMEDICO AG · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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, 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 (tumour registry platform) to describe treatment in routine clinical practice of myelofibrosis patients in routine care in Germany. The registry 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 clinical registry 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 clinical registry 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
- Myelofibrosis
Timeline
- Start date
- 2026-02-19
- Primary completion
- 2031-09-01
- Completion
- 2031-09-01
- First posted
- 2025-05-16
- Last updated
- 2026-03-30
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT06976918. Inclusion in this directory is not an endorsement.