10 results
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: To determine the feasibility of Laromustine when given at three possible dose levels together with standard induction cycles I and II in patients with AML/ RAEB with IPSS³1.5 in a prospective comparison to standard…
The primary objective of this study is to assess the efficacy of gabapentin as add-on to morphine for the treatment of severe chronic neuropathic or mixed pain in children from 3 months to less than 18 years of age. Secondary objectives 1. To assess…
• 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…
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 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…