Research Platform Myelofibrosis and Anemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Primary Myelofibrosis, Secondary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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)
Overview
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.
Primary outcome measures
- Documentation of systemic treatment for MF and therapy sequences [Time frame: 3 years per patient]
Secondary outcome measures (7)
- 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]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Germany · 1 center
- Multiple sites all over Germany — Multiple Locations
Identifiers
NCT: NCT06976918 · iOM-110507