13 results
Primary objective:To determine the effect of obesity (BMI > 40kg/m2) on the pharmacokinetics of micafungin and develop a dosing regimen for obese patients. Secondary objective:* To describe the pharmacokinetics of the approved dose of 200mg…
Primary Objectives:To assess the incidence and the time to confirmed IFI in subjects treated pre-emptively with micafungin versus placebo.
Primary objective(s)• To evaluate the efficacy of blinatumomab to induce complete MRD responseKey secondary objective for patients with Ph-negative ALL • To evaluate the effect of blinatumomab on hematological relapseOther Secondary objectives• To…
Primary objectivesPart A of the study (if applicable):1. To assess the safety and tolerability of tosedostat added to standard induction chemotherapy for AMLand select the feasible dose level for part B of the study2. To assess in a randomized…
Primary Objectives 1. To evaluate the pharmacokinetics of fluconazole and micafungin both administered after randomization in neonates with suspected or culture-proven Candidiasis in order to validate their optimal dosage and identify covariates…
The new drug delivery device is a rod-shaped metal bar, called an ocular coil. The coil can be loaded with one (or more) drug(s) en can be placed easily in the lower eyelid of the eye. In this way, the drug can be released to the eye in a constant…
The primary objective is to improve the outcome (in terms of event-free survival (EFS) as the primary endpoint) of newly diagnosed KMT2A-rearranged (KMT2A-r) infant acute lymphoblastic leukemia (ALL) compared with the historical results of the…
Primary objective:-To assess the proportion of patients that achieve MRD negative response (by PCR/FCM) after the first consolidation phase including blinatumomab.Secondary objectives:-To assess the MRD level following induction chemotherapy-To…
• Primary- To determine the maximum tolerated dose (MTD) of blinatumomab in combination with pembrolizumab in adult subjects with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL).• Secondary-To evaluate the safety, efficacy, and…
The primary objective of the study is to assess the safety of 1 course of blinatumomab added to the Interfant-06 backbone in infants with newly diagnosed ALL. The secondary objectives are: • to assess the feasibility• to define the preliminary…
Primary:• To compare event-free survival (EFS) of subjects receiving blinatumomab alternating with low-intensity chemotherapy to EFS of subjects receiving standard of care (SOC) chemotherapy• To compare overall survival (OS) of blinatumomab…
Primary :• To evaluate the safety and tolerability of blinatumomab incombination with AMG 404 in adults with R/R B-ALL• To estimate the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of AMG 404 when combined with cIV…
Primary:Dose Escalation• Evaluate the safety and tolerability of subcutaneous (SC) blinatumomab for treatment of Relapsed or Refractory B cell Precursor Acute Lymphoblastic Leukemia (R/R B-ALL)• Determine the maximum tolerated dose (MTD) and…