German MPN-Registry for BCR-ABL 1-Negative Myeloid Neoplasms (Study Group Ulm)

Condition(s) studied

Investigational drug(s) / intervention(s)

Study summary

To register a large number of patients with the diagnosis of a BCR-ABL 1- negative myeloid neoplasm (according to WHO 2008 / 2016 classification) in participating centers

To store samples from all patients (e.g. bone marrow aspirate, peripheral blood, plasma, and buccal swap, skin biopsy samples in exceptional cases)

To perform morphologic and genetic analyses

To assess clinical characteristics and outcome data using a defined catalogue containing clinically relevant variables

To assess biological disease features and correlate with clinical outcome data (prognostic and predictive markers)

To assess quality of life

Eligibility

Primary outcome measure(s)

• Treatment decision — 25 years
  Treatment decision (watch and wait, standard, investigational)
• Response — 25 years
  Response of treatment
• Overall survival — 25 years
  Survival over the whole study duration
• Progression-free-survival — 25 years
  Survival without any progression
• Duration of response — 25 years
  Duration of response over the whole study duration
• Quality of life assessed by the Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF Protocol 5/25/11, EORTC QLQ-C30, FACT-Lym (Fassung 4)), supplemented by information on self-assessed concomitant diseases and demographics. — 25 years
  Quality of life assessed by the Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF Protocol 5/25/11, EORTC QLQ-C30, FACT-Lym (Fassung 4)), supplemented by information on self-assessed concomitant diseases and demographics.

Trial sites (30)

More University of Ulm trials in Germany