The main objective of this study is to evaluate the safety and efficacy of SC blinatumomab in children below 12 years of age.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Phase 1b: Number of Participants who Experienced Dose Limiting Toxicities (DLTs)
Timeframe: Up to 29 days
Phase 1b: Number of Participants who Experienced Treatment-emergent Adverse Events (TEAEs)
Timeframe: Up to approximately 7 months
Phase 1b: Number of Participants who Experienced Serious TEAEs
Timeframe: Up to 2 years and 7 months
Phase 1b: Number of Participants who Experienced Treatment-related TEAEs
Timeframe: Up to approximately 7 months
Phase 1b: Number of Participants who Experienced AEs of Interest (EOI)
Timeframe: Up to approximately 7 months
Phase 2; R Cohort: Number of Participants who had Complete Remission/Complete Remission with Partial Hematological Recovery (CR/CRh) Within the First 2 Cycles
Timeframe: Up to 70 days
Phase 2; M Cohort: Number of Participants who had CR with MRD Negative Response Within the First 2 Cycles
Timeframe: Up to 70 days