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A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, SINGLE AND MULTIPLE ASCENDING DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS AND THE EFFECT OF FOOD AND KETOCONAZOLE ON THE PHARMACOKINETICS OF IPI-145 WHEN ADMINISTERED TO HEALTHY ADULT SUBJECTS

The study will be performed in 3 parts, Parts 1, 2 , 3. and 4 (DDI). The purpose of the study is to investigate how safe the compound is and how well the compound is tolerated; this will be investigated in all study parts. In Parts 1 and 2, it will…

Development and introduction of a pediatric liquid formulation of mercaptopurine for treatment of leukemia

The aim of this study is to improve 6MP treatment in pediatric leukemia patients, by developing and licensing a pediatric liquid formulation of 6MP, assessing its stability and bioequivalence, and ensuring a nationwide introduction of the new…

Double blind placebo controlled randomized intervention study to validate the beneficial effect of hydrocortisone on dexamethasone-induced neurobehavioral side effects in pediatric acute lymphoblastic leukemia

The primary aim is to validate the finding that addition of physiological doses of hydrocortisone reduces dexamethasone-induced clinically relevant neurobehavioral problems. The secondary aims are to study the role of genetic variation, psychosocial…

A phase 3, multi-center, open-label, randomized study of oral ABL001 versus bosutinib in patients with Chronic Myelogenous Leukemia in chronic phase (CML-CP), previously treated with 2 or more tyrosine kinase inhibitors (CABL001A2301)

Primary: To compare the Major Molecular Response (MMR) rate at 24 weeks of ABL001 versus bosutinibSecondary: To compare additional parameters of the efficacy of ABL001 versus bosutinib. Safety, tolerability.

A Phase 3, multicenter, open-label, randomized study to evaluate the efficacy and safety of fedratinib compared to best available therapy in subjects with DIPSS - intermediate or high-risk primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis and previously treated with ruxolitinib

The primary objective of the study is to evaluate the percentage of subjects with at least 35%spleen volume reduction in the fedratinib and the BAT arms.The secondary objectives are:• To evaluate the percentage of subjects with at least 50%…