A Study Evaluating Subcutaneous Versus Intravenous Blinatumomab in Newly Diagnosed Adults with B-cell Precursor Acute Lymphoblastic LeukaemiaAUDAX
Study Details
The main objective of this trial is to demonstrate that subcutaneous (SC) blinatumomab in conjunction with chemotherapy (Arm B) is non-inferior to continuous intravenous infusion (cIV) blinatumomab in conjunction with chemotherapy (Arm A) in overall survival (OS) in newly diagnosed participants with Philadelphia chromosome (Ph) negative B-cell precursor acute lymphoblastic leukemia (B-ALL) who are in complete remission (CR) or CR with incomplete peripheral count recovery (CRi) after induction.
Protocol Summary
Overall Survival (OS)
Timeframe: Up to 5 years from randomization
Number of Participants who Experience Treatment-emergent Adverse Events (TEAEs)
Timeframe: Up to 5 years from randomization
Area Under the Concentration-time Curve in Cycle 1 (AUCcycle 1) for SC Blinatumomab
Timeframe: Up to Cycle 1 Day 35 (Cycle length = 35 days)
AUCcycle 1 for cIV Blinatumomab
Timeframe: Up to Cycle 1 Day 35 (Cycle length = 35 days)
Average Concentration Following Cycle 1 Day 19 Dosing (Cavgd19dose) for SC Blinatumomab
Timeframe: From predose on Cycle 1 Day 19 to predose on Cycle 1 Day 22 (Cycle length = 35 days)
Steady-state Concentration (Css) for cIV Blinatumomab
Timeframe: Up to Cycle 1 Day 29 (Cycle length = 35 days)
Relapse-free Survival (RFS)
Timeframe: Up to 5 years from randomization
Number of Participants With CR With MRD Response
Timeframe: Up to 5 years from randomization
Number of Participants With Deep CR With MRD Response
Timeframe: Up to 5 years from randomization
Change from Day 1 Consolidation Cycle 1 to End of Consolidation in Role Functioning as Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Timeframe: Consolidation Cycles 1, 2, 5 and 6 Day 1 (Cycles length=35 days); Consolidation Cycles 3, 4, 7 and 8 Day 15 (Cycles length=2-4 weeks); Maintenance Cycle 1 Day 1 (Cycle length=28 days)
Change from Day 1 Consolidation Cycle 1 to End of Consolidation in Overall Quality of Life as Measured by EORTC QLQ-C30
Timeframe: Consolidation Cycles 1, 2, 5 and 6 Day 1 (Cycles length=35 days); Consolidation Cycles 3, 4, 7 and 8 Day 15 (Cycles length=2-4 weeks); Maintenance Cycle 1 Day 1 (Cycle length=28 days)
Change from Day 1 Consolidation Cycle 1 to End of Consolidation in All Other Domains/Items as Measured by EORTC QLQ-C30
Timeframe: Consolidation Cycles 1, 2, 5 and 6 Day 1 (Cycles length=35 days); Consolidation Cycles 3, 4, 7 and 8 Day 15 (Cycles length=2-4 weeks); Maintenance Cycle 1 Day 1 (Cycle length=28 days)
Change From Day 1 Consolidation Cycle 1 to End of Consolidation in the Visual Analogue Scale (VAS)
Timeframe: Consolidation Cycles 1, 2, 5 and 6 Day 1 (Cycles length=35 days); Consolidation Cycles 3, 4, 7 and 8 Day 15 (Cycles length=2-4 weeks); Maintenance Cycle 1 Day 1 (Cycle length=28 days)
Percentage of Time on Treatment With High Side Effect Bother From Consolidation Cycle 1 to End of Consolidation
Timeframe: Consolidation Cycle 1 up to Day 8 and then weekly until end of Consolidation Cycle (Cycle length = 35 days)