Revolutionary study in Dresden: Ivosidenib improves leukemia therapy!

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The TU Dresden is conducting the PIVOT study with Kiel to test ivosidenib in acute myeloid leukemia and improve chances of survival.

Die TU Dresden führt mit Kiel die PIVOT-Studie durch, um Ivosidenib bei akuter myeloischer Leukämie zu testen und Überlebenschancen zu verbessern.
The TU Dresden is conducting the PIVOT study with Kiel to test ivosidenib in acute myeloid leukemia and improve chances of survival.

Revolutionary study in Dresden: Ivosidenib improves leukemia therapy!

Acute myeloid leukemia (AML) is an aggressive form of blood cancer that is associated with a high risk of relapse. Even after a stem cell transplant, this risk remains significant, which makes the search for effective treatment options imperative. Therefore, the PIVOT clinical study is starting, which is being carried out by scientists from the Technical University of Dresden and the University of Kiel. The aim of this groundbreaking study is to test the new drug ivosidenib.

Ivosidenib was approved in Europe in 2023 for the treatment of AML and shows particularly promising results in patients with an IDH1 mutation. This mutation is detectable in approximately 6-8% of adult AML patients. In Germany, around 400 people with IDH1 mutation develop blood cancer every year. Despite the possibility of allogeneic stem cell transplantation, the risk of relapse remains high in these patients.

Aim of the PIVOT study

The PIVOT trial is focused on testing the effectiveness of ivosidenib in reducing the risk of molecular relapse and improving patients' chances of survival. This long-term survival prognosis is crucial for the treating physicians and the participants in the study. The National Center for Tumor Diseases in Dresden, an institution that specializes in cancer research, also supports comprehensive research.

The study design includes several phases: First, there is a screening phase in which patients are enrolled within 100 days after the transplant. This is followed by a treatment phase in which ivosidenib is administered daily for 24 months. Finally, there is a follow-up phase with survival and safety checks that last up to five years after the end of therapy.

Medical management and support

The study is being carried out by experienced physicians Dr. Jan Moritz Middeke from the University Hospital of Dresden and Prof. Friedrich Stölzel from the University Hospital of Schleswig-Holstein. The implementation of the PIVOT study is also supported by the Study Alliance Leukemia, the AML Cooperative Group and the Cooperative Transplant Study Group. Financing is provided by Servier Germany, the Technical University of Dresden and the Study Alliance Leukemia.

Participation in the study is open to adults aged 18 years and over with a confirmed IDH1-mutant AML or post-transplant myelodysplastic syndrome (MDS) diagnosis. This innovative approach could play an important role in the treatment of leukemia patients in the future.

Further information is available on the websites of Technical University of Dresden and Oncopedia to find.