Will Be Recruiting
Sponsor ID
20240113

A Study Evaluating Subcutaneous Versus Intravenous Blinatumomab in Newly Diagnosed Adults with B-cell Precursor Acute Lymphoblastic LeukaemiaAUDAX

Sponsor ID
20240113
Clinicaltrials.gov ID
NCT07223190
EUCTIS ID
N/A
EudraCT ID
2025-523291-23

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.

Additional Study Details

Phase
Phase 3
Product
blinatumomab
Type
Interventional
Masking
None (Open Label)
Enrollment
560
Additional Study Details

Protocol Summary

Primary Outcome Measures

Overall Survival (OS)

Timeframe: Up to 5 years from randomization

Secondary Outcome Measures

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)

Locations

No locations found.