Study Complete
Sponsor ID
20190177
Blinatumomab in Combination With AMG 404 for the Treatment of Adults with Relapsed or Refractory B cell Precursor ALL
Study Details
The primary objective of this phase 1b study is to evaluate the safety and tolerability of blinatumomab and AMG 404 in combination in adults with R/R B-ALL and to estimate the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of AMG 404 when combined with continuous intravenous infusion (cIV) blinatumomab.
Protocol Summary
Primary Outcome Measures
Number of Participants who Experience Dose-Limiting Toxicities (DLTs)
Timeframe: Up to 8 Weeks
Number of Participants who Experience Treatment-Emergent Adverse Events (TEAEs)
Timeframe: Up to 51 Weeks
Number of Participants who Experience Serious Treatment-Emergent Adverse Events
Timeframe: Up to 51 Weeks
Number of Participants who Experience Treatment-Related Treatment-Emergent Adverse Events
Timeframe: Up to 51 Weeks
Number of Participants who Experience Adverse Events of Interest (EOI)
Timeframe: Up to 51 Weeks
Secondary Outcome Measures
Rate of Complete Remission (CR) Including Complete Remission with Partial Hematological Recovery (CRh*)
Timeframe: Up to 51 Weeks
Complete Remission (CR) Rate
Timeframe: Up to 51 Weeks
Duration of Complete Remission (CR)
Timeframe: Up to 51 Weeks
Duration of Complete Remission (CR) or Complete Remission with Partial Hematological Recovery (CRh*)
Timeframe: Up to 51 Weeks
Steady State Concentrations (Css) of Blinatumomab
Timeframe: Up to 35 Weeks
Maximum Observed Concentration (Cmax) of AMG 404
Timeframe: Up to 51 Weeks
Time to Maximum Observed Concentration (Tmax) of AMG 404
Timeframe: Up to 51 Weeks
Area Under the Plasma Concentration-Time Curve (AUC) of AMG 404
Timeframe: Up to 51 Weeks
Number of Participants with Incidences of Anti-Blinatumomab Antibodies
Timeframe: Up to 35 Weeks
Number of Participants with Incidences of Anti-AMG 404 Antibodies
Timeframe: Up to 35 Weeks
Locations
Location
Royal Adelaide Hospital
Adelaide, SA, Australia, 5000
Status
Recruiting
Location
University of Texas MD Anderson Cancer Center
Houston, TX, United States, 77030
Status
Recruiting
Location
Cleveland Clinic Taussig Cancer Center
Cleveland, OH, United States, 44195
Status
Recruiting
Location
City of Hope National Medical Center
Duarte, CA, United States, 91010
Status
Recruiting
Location
Universitätsklinikum Schleswig-Holstein
Kiel, Germany, 24105
Status
Recruiting
Location
Ordensklinikum Linz Elisabethinen
Linz, Austria, 4020
Status
Recruiting
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