12 results
Objective of this study is to determine the efficacy of midostaurin in patients with ASM or MCL with/without an associated hematological clonal non-mast cell lineage disease.
To define and implement an uniform initial evaluation and stratification on adult patients with LCH, to uniform the treatment of adult patients with LCH and to improve treatment results with respect to survival, therapy response, prevention of…
To determine if the addition of midostaurin to daunorubicin/ cytarabine induction, high dose cytarabine consolidation, and continuation therapy improves overall survival (OS) in both the mutant FLT3-ITD and FLT-3 TKD AML patients.
To assess the effect of two withdrawal strategies over two years in patients with stable remission for more than 8 months on combination therapy with infliximab and antimetabolites, and demonstrate that continued combination of infliximab and…
The primary objective of this study is to evaluate the efficacy of optimized thiopurine therapy. Secondary objectives are a cost-utility and budget impact analysis of optimized thiopurine therapy and the identification of biomarkers in mucosal…
Primary: To determine the MTD and/or RDE of LGH447 with or without midostaurin. Secondary: 1. To characterize the safety and tolerability of LGH447 with or without midostaurin at the MTD and/or RDE.2. To assess any observed antitumor activity of…
Primary objective:To evaluate the safety and tolerability of KY1005.Secondary objectives:To evaluate the pharmacokinetics (PK) of KY1005 following single and repeat doses.Exploratory objectives:- To evaluate the immunogenicity of KY1005;- To assess…
This is a phase I/II pediatric dose-ranging study that will evaluate the safety, tolerability and pharmacokinetics of midostaurin in children <18 years of age and >= 3 months who have relapsed or refractory leukemias that may benefit…
Primary: To study the efficacy and tolerability of Midostaurin in patients with indolent or smoldering systemic mastocytosis on mediator symptom reduction.Secondary: 1) To study whether Midostaurin can reduce mast cell infiltration and 2) to assess…
Primary objective:To asses the safety and feasibility of post-transplant panobinostat combined with midostaurin in patients with adverse risk AML/RAEB with FLT3-ITD with high allelic ratio in terms of dose limiting toxicity.Secondary objectives:To…
Primary objectives:- To assess in a randomized comparison the effect of midostaurin added to 10-day decitabine treatment on the cumulative CR/CRi rate during 3 cycles.Secondary objectives:- To assess the safety and tolerability of midostaurin added…
To compare OS between gilteritinib and midostaurin in combination with induction therapy and consolidation therapy followed by one-year maintenance therapy in patients with newly diagnosed AML with a FLT3 gene mutation eligible for intensive…