Trial Clinici

Terza Missione Trial Clinici


Valutazione dell'efficacia del prodotto in studio vs placebo nei pazienti con atrofia multisistemica. Studio multicentrico internazionale in doppio cicco verso placebo.

Codice EudraCT2018-003289-15
Inizio sperimentazione29 Novembre 2019

Valutazione dell'efficacia del prodotto in studio vs placebo nei pazienti con atrofia multisistemica. Studio multicentrico internazionale in doppio ciclo verso placebo.

Codice EudraCT2018-003941-41
Inizio sperimentazione6 Novembre 2019

Valutazione dell'efficacia del prodotto in studio vs placebo nei pazienti con atrofia multisistemica. Studio multicentrico internazionale in doppio ciclo verso placebo.

Codice EudraCT2018-004145-16
Inizio sperimentazione2 Ottobre 2019
Codice EudraCT2015-000966-72
Periodo sperimentazione16 Agosto 2019 - 12 Ottobre 2019
Codice EudraCT2017-002426-20
Periodo sperimentazione5 Aprile 2019 - 31 Dicembre 2019

A phase II, single-arm, multicenter study of full treatment-free remission in patients with chronic myeloid leukemia in chronic phase treated with nilotinib in first-line therapy who have achieved a sustained deep molecular response for at least 1 year: DANTE study.

Treatment with tyrosine kinase inhibitors (TKIs) can achieve durable cytogenetic and molecular remissions and substantially improve survival in most patients. There is reasonable expectation not only of improving survival further but also of curing the disease since a high percentage of patients reach deep molecular response (DMR).

Stopping TKI treatment would be an innovative and cost-effective way to optimize available therapy concepts. Several studies have shown that ~40% of patients in stable, deep molecular response remain in treatment-free remission (TFR) after stopping first-line treatment. Discontinuing treatment with TKIs would provide chronic myeloid leukemia (CML) patients with several benefits, such as the elimination of medication side effects, reduced financial burden, the ability to safely attempt pregnancy and improved quality of life.

The purpose of the present study is to evaluate the rate of full treatment-free molecular remission in a selected population of CML-CP patients treated with nilotinib at half the standard dose during a consolidation period of 12 months, followed by complete therapy cessation. The study also seeks to provide evidence that suspending nilotinib therapy or maintaining nilotinib at half the standard dose for those patients not eligible for TFR does not cause short or long-term harm to them. Moreover, the consolidation period will provide evidence that step-by-step discontinuation may decrease the rate of symptoms associated with drug withdrawal during TFR.

The primary objective of this study is to determine the percentage of patients in full treatment-free remission 96 weeks after the start of the consolidation phase.

Codice EudraCT2018-002898-21
Inizio sperimentazione1 Marzo 2019