About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
No systemic therapy for diagnosed primary or secondary MF.
Planned allogenic stem cell transplantation (allo-SCT) or active participation in an interventional clinical trial.
Trial population
Adult patients with primary myelofibrosis or post-polycythemia vera or post-essential thrombocythemia myelofibrosis (MF) with anemia
Trial design
Other
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Documentation of systemic treatment for MF and therapy sequences
Types and frequencies of systemic treatment for MF during observation time.
Secondary outcomes
Hematologic response
Frequencies of hematologic response (improved, stable, worsened) per line of treatment
Splenic response
Frequencies of splenic response (improved, stable, worsened) per line of treatment
Overall response rate (ORR)
Documentation of ORR per line of treatment
Progression free survival (PFS)
Documentation of PFS per line of treatment
Locations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
iOMEDICO AG
Lead sponsor
German Study Group for Myeloproliferative Neoplasms (GSG-MPN)
Collaborator