Research Platform Myelofibrosis and Anemia

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsoriOMEDICO AG

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 volunteers

Qualifiers

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

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Documentation of systemic treatment for MF and therapy sequences

Types and frequencies of systemic treatment for MF during observation time.

Time frame
3 years per patient

Secondary outcomes

1

Hematologic response

Frequencies of hematologic response (improved, stable, worsened) per line of treatment

Time frame
3 years per patient
2

Splenic response

Frequencies of splenic response (improved, stable, worsened) per line of treatment

Time frame
3 years per patient
3

Overall response rate (ORR)

Documentation of ORR per line of treatment

Time frame
3 years per patient
4

Progression free survival (PFS)

Documentation of PFS per line of treatment

Time frame
3 years per patient

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Multiple sites all over GermanyRecruiting Multiple LocationsGermanyGermany

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