IOMEDICO AG

The primary objective of this non interventional study is to evaluate symptom burden in adult patients with PV without symptomatic splenomegaly during treatment with ropeginterferon alfa-2b in a real-world setting. Further patient-relevant endpoints include effectiveness including complete hematologic response (CHR), event-free survival (EFS), safety and tolerability, treatment reality including dosing details as well as factors affecting treatment decision making.

The goal of this prospective, observational study INTEREST is to collect real-world data on ripretinib treatment in a broad patient population in Germany. Ripretinib will be administered according to the current SmPC. Thus, INTEREST will evaluate for the first time ripretinib in GIST patients in a real-world setting in Germany.
The main questions the study aims to answer are:
* Evaluate quality of live (QoL) using the questionnaire EQ-5D-5L to gain knowledge about how ripretinib treatment affects GIST patients' well-being (change compared to Baseline, Time to Deterioration)
* Assessment of effectiveness in routine treatment (Progression-Free Survival, Overall Survival, Best Response, Overall Response Rate, Disease Control Rate
* Assessment of drug safety
* Assessment of parameters of physicians' treatment decision making
* Description of treatment reality in detail

Cholangiocarcinoma is a rare and aggressive tumor of the bile duct associated with a poor prognosis and very limited treatment options. The IDH1 inhibitor ivosidenib provides a new, targeted treatment option for this disease. Ivosidenib was approved by European Medicines Agency (EMA) in May 2023 as monotherapy in adult patients with locally advanced or metastatic cholangiocarcinoma with an IDH1 R132 mutation who were previously treated by at least one prior line of systemic therapy.
The prospective, multicenter, observational study IDHIRA will collect first real-world data on ivosidenib treatment in a broad patient population in Germany. Ivosidenib will be administered according to the current SmPC. Thus, IDHIRA will generate real-world evidence on effectiveness, quality of life (QoL) and safety of ivosidenib.