Registry Platform Myelofibrosis and Anemia

NCT06976918 | Recruiting

• 1 other identifier: iOM-110507
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Documentation of systemic treatment for MF and therapy sequences

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

  3 years per patient

Secondary Outcomes (7)

• Hematologic response

  3 years per patient

• Splenic response

  3 years per patient

• Overall response rate (ORR)

  3 years per patient

• Progression free survival (PFS)

  3 years per patient

• Overall survival

  3 years per patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with primary myelofibrosis or post-polycythemia vera or post-essential thrombocythemia myelofibrosis (MF) with anemia

You may qualify if:

• 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.

You may not qualify if:

• No systemic therapy for diagnosed primary or secondary MF.
• Planned allogenic stem cell transplantation (allo-SCT) or active participation in an interventional clinical trial.

Sponsors & Collaborators

• German Study Group for Myeloproliferative Neoplasms (GSG-MPN): collaborator
• iOMEDICO AG: lead

Study Sites (1)

Multiple sites all over Germany

Multiple Locations, Germany

RECRUITING

MeSH Terms

Conditions

Primary Myelofibrosis; Anemia

Condition Hierarchy (Ancestors)

Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Konstanze Döhner, Prof. Dr. med.

  University Hospital Ulm, Germany

  STUDY CHAIR

• Steffen Koschmieder, Prof. Dr. med.

  University Hospital Aachen, Germany

  STUDY CHAIR

Central Study Contacts

iOMEDICO AG

CONTACT

+4976115242; info@iomedico.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 16, 2025
• Study Start: February 19, 2026
• Primary Completion (Estimated): September 1, 2031
• Study Completion (Estimated): September 1, 2031
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)