Registry Platform Myelofibrosis and Anemia
- Conditions
- Primary MyelofibrosisPost-essential Thrombocythemia MyelofibrosisMyelofibrosisSecondary MyelofibrosisAnemiaMyelofibrosis; AnemiaPost-polycythemia Vera Myelofibrosis
- Registration Number
- NCT06976918
- Lead Sponsor
- iOMEDICO AG
- 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, 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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.
- No systemic therapy for diagnosed primary or secondary MF.
- Planned allogenic stem cell transplantation (allo-SCT) or active participation in an interventional clinical trial.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Documentation of systemic treatment for MF and therapy sequences 3 years per patient Types and frequencies of systemic treatment for MF during observation time.
- Secondary Outcome Measures
Name Time Method Overall survival 3 years per patient Documentation of OS per line of treatment
Hematologic response 3 years per patient Frequencies of hematologic response (improved, stable, worsened) per line of treatment
Splenic response 3 years per patient Frequencies of splenic response (improved, stable, worsened) per line of treatment
Assessment of Myelofibrosis-related symptoms 3 years per patient Myelofibrosis Symptom Assessment form (MFSAF) questionnaire 7-day Recall
Overall response rate (ORR) 3 years per patient Documentation of ORR per line of treatment
Health-related quality of life (Patient-reported outcome, PRO) 3 years per patient 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)
Progression free survival (PFS) 3 years per patient Documentation of PFS per line of treatment
Trial Locations
- Locations (1)
Multiple sites all over Germany
🇩🇪Multiple Locations, Germany
Multiple sites all over Germany🇩🇪Multiple Locations, Germany