6 results
Primary ObjectiveThe primary objective of this study will be to compare the efficacy of infliximab with that of placebo in the prevention of clinical recurrence of CD through Week 76, defined as a composite endpoint that requires endoscopic…
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 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…
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: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…
The primary objective of this randomized controlled trial is to investigate the efficacy of dashboard driven dosing of infliximab compared to standard dosing during the induction phase in patients with acute severe ulcerative colitis, as evaluated…