The primary purpose of the study is to evaluate whether biweekly administered XEMBIFY® plus Standard Medical Treatment (SMT) over a one-year period will reduce the rate of major bacterial infections per participant per year in B-cell CLL, MM, and NHL participants with hypogammaglobulinemia (HGG) in comparison to the Placebo plus SMT group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
386
GC2202 Study Site 103
St. Petersburg, Florida, United States
RECRUITINGGC2202 Study Site 111
Bethesda, Maryland, United States
RECRUITINGGC2202 Study Site 109
Greenville, North Carolina, United States
RECRUITINGGC2202 Decentralized Study Site 114
Morrisville, North Carolina, United States
Annual Rate of Major Bacterial Infections per Year
Time frame: Up to Week 51
Time to First Onset of Major Bacterial Infection
Time frame: Up to Week 51
Percentage of Participants who Experience Major Bacterial Infections
Time frame: Up to Week 51
Rate of all Bacterial Infections Determined by the Investigator
Time frame: Up to Week 51
Percentage of Participants who Experience Bacterial Infections
Time frame: Up to Week 51
Time to First Onset of Non-Major Bacterial Infections
Time frame: Up to Week 51
Number of Days on Which Participants Were on Antibiotics
Time frame: Up to Week 51
Number of Hospitalizations due to any Infections
Time frame: Up to Week 51
Duration of Hospitalizations due to any Infections
Time frame: Up to Week 51
Number of Hospitalizations due to Major Bacterial Infections
Time frame: Up to Week 51
Duration of Hospitalizations due to Major Bacterial Infections
Time frame: Up to Week 51
Rate of all Infections as Determined by the Investigator
Time frame: Up to Week 51
Number of Participants with Validated Infections
Time frame: Up to Week 51
Time to First Onset of any Infection
Time frame: Up to Week 51
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
GC2202 Study Site 105
Canton, Ohio, United States
RECRUITINGGC2202 Study Site 110
Rockville, South Carolina, United States
WITHDRAWNGC2202 Study Site 702
Banja Luka, Bosnia and Herzegovina
RECRUITINGGC2202 Study Site 703
Mostar, Bosnia and Herzegovina
RECRUITINGGC2202 Study Site 701
Sarajevo, Bosnia and Herzegovina
NOT_YET_RECRUITINGGC2202 Study Site 202
Burgas, Bulgaria
RECRUITING...and 51 more locations