Registry Platform Myelofibrosis and Anemia (RHODOLITE)

iOMEDICO

Status: Begins enrollment this month

Conditions: Anemia; Myelofibrosis; Post-essential Thrombocythemia Myelofibrosis; Post-polycythemia Vera Myelofibrosis; Secondary Myelofibrosis; Primary Myelofibrosis; Myelofibrosis; Anemia

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT06976918

iOM-110507

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.