* A phase III trial intends to use an adaptive dosing method, where the dosage of Givinostat is adjusted every 28 days based on patient blood results, informed by a developed simulation platform.
* Initial simulations suggest that smaller, more frequent adjustments in Givinostat dosage improve patients' chances of achieving a complete hematological response while reducing the occurrence of serious side effects compared to larger adjustments.
Polycythemia vera (PV) is a type of blood cancer where the bone marrow produces too many blood cells, mostly due to a mutation in the JAK2 gene.
Givinostat, a drug that inhibits cell growth related to JAK2, has shown positive results in earlier studies, prompting a long-term study on its effects in patients with PV.
Over a 4-year follow-up of patients, givinostat was found to have a good safety profile, with only 10% experiencing serious side effects, while more than 80% showed positive treatment responses.
Givinostat, an HDAC inhibitor, has shown effectiveness in treating patients with the JAK2 V617F mutation and chronic myeloproliferative neoplasms.
In a phase II study, 44 polycythaemia vera patients unresponsive to hydroxycarbamide were treated with Givinostat and the response rate after 12 weeks was 55% for the 50 mg group and 50% for the 100 mg group.
The treatment was well tolerated, with only 18% of patients discontinuing due to side effects, suggesting that Givinostat combined with hydroxycarbamide is a safe and effective option for these patients.
A phase II study assessed the safety and effectiveness of Givinostat, a histone-deacetylase inhibitor, in patients with Polycythaemia Vera, Essential Thrombocythaemia, and Myelofibrosis who have the JAK2V617F mutation.
The treatment involved administering Givinostat orally for 24 weeks, with some patients requiring dose adjustments or discontinuation due to side effects or disease progression.
Results showed promising responses, especially among Polycythaemia Vera and Essential Thrombocythaemia patients, with improvements in symptoms like pruritus and splenomegaly, indicating Givinostat's potential as a tolerated treatment option.