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| Name | Class |
|---|---|
| German Study Group for Myeloproliferative Neoplasms (GSG-MPN) | UNKNOWN |
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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.
RHODOLITE is a national, prospective, open-label, longitudinal, non-interventional multicenter cohort study (research platform) to describe treatment in routine clinical practice of myelofibrosis patients in routine care in Germany.
RHODOLITE 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 project 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 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.
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| Measure | Description | Time Frame |
|---|---|---|
| Documentation of systemic treatment for MF and therapy sequences | Types and frequencies of systemic treatment for MF during observation time. | 3 years per patient |
| Measure | Description | Time Frame |
|---|---|---|
| Hematologic response | Frequencies of hematologic response (improved, stable, worsened) per line of treatment | 3 years per patient |
| Splenic response | Frequencies of splenic response (improved, stable, worsened) per line of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients with primary myelofibrosis or post-polycythemia vera or post-essential thrombocythemia myelofibrosis (MF) with anemia
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| iOMEDICO AG | Contact | +4976115242 | 0 | info@iomedico.com |
| Name | Affiliation | Role |
|---|---|---|
| Konstanze Döhner, Prof. Dr. med. | University Hospital Ulm, Germany | Study Chair |
| Steffen Koschmieder, Prof. Dr. med. | University Hospital Aachen, Germany | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple sites all over Germany | Recruiting | Multiple Locations | Germany |
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| ID | Term |
|---|---|
| D055728 | Primary Myelofibrosis |
| D000740 | Anemia |
| ID | Term |
|---|---|
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| 3 years per patient |
| Overall response rate (ORR) | Documentation of ORR per line of treatment | 3 years per patient |
| Progression free survival (PFS) | Documentation of PFS per line of treatment | 3 years per patient |
| Overall survival | Documentation of OS per line of treatment | 3 years per patient |
| Health-related quality of life (Patient-reported outcome, PRO) | 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) | 3 years per patient |
| Assessment of Myelofibrosis-related symptoms | Myelofibrosis Symptom Assessment form (MFSAF) questionnaire 7-day Recall | 3 years per patient |