7 results
This is a phase I/II trial of the EORTC Leukemia Group and the italian GIMEMA Acute Leukemia Working Party. In a phase I setting we will investigate the optimal dosage and route of administration (one hour infusion or intravenous injection) of…
Primary: Time to first occurrence of MACE (cardiovascular death, myocardial infarction, or stroke) [Non-inferiority].Secondary: Time to first occurrence of MACE [Superiority], MACE or urgent revascularization for unstable angina, individual…
Primary objectivesFor part A of the study: -To determine the feasibility of Clofarabine when given at three possible dose levels together with standard induction cycles I and II in patients with AML/ RAEB with IPSS>=1.5 in a prospective…
Parts D and E: Primary Objectives:• To evaluate the safety and tolerability of VX-445 in TC with TEZ and IVA in subjects with cystic fibrosis (CF)• To evaluate the efficacy of VX-445 in TC with TEZ and IVA in subjects with CFSecondary Objectives• To…
Primary objectives:1.The fesibility of clofarabine when given together with standard prephase chemotehrapy in a prospective comparison to standard prephase chemotherapy (prednison). 2.To evaluate the effect of clofarabin when combined with prephase…
The primary objective of the randomized part of the protocol is to investigate if a conditioning regimen containing one alkylator (Bu) combined with two antimetabolites (Clo and Flu) results in superior 2-year acute grade III to IV-free, chronic non…
Primary objective:•To establish the recommended phase 2 dose of Vyxeos®/CPX-351 in combination with clofarabine in children with relapsed/refractory AML Secondary objectives:•To determine the safety and tolerability of this combination•To determine…