A Study to Evaluate Efficacy, Safety, and PK of XEMBIFY®+Standard Medical Treatment (SMT) Compared to Placebo+SMT to Prevent Infections in Participants With HGG and Recurrent or Severe Infections Associated With B-cell Chronic Lymphocytic Leukemia, Multiple Myeloma, and Non-Hodgkin Lymphoma
Start Date
12/26/2022
Completion Date
8/1/2029
Summary
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Xembify
Placebo
Conditions
Locations
GC2202 Study Site 115
Huntington Park, California 90255
United States
GC2202 Study Site 103
St. Petersburg, Florida 33701
United States
GC2202 Study Site 111
Bethesda, Maryland 20889
United States
GC2202 Study Site 109
Greenville, North Carolina 27843
United States
GC2202 Decentralized Study Site 114
Morrisville, North Carolina 27560
United States
GC2202 Study Site 105
Canton, Ohio 44718
United States
GC2202 Study Site 110
Rockville, South Carolina 29732
United States
GC2202 Study Site 702
Banja Luka, 780000
Bosnia and Herzegovina
GC2202 Study Site 703
Mostar, 88000
Bosnia and Herzegovina
GC2202 Study Site 701
Sarajevo, 71000
Bosnia and Herzegovina
GC2202 Study Site 202
Burgas, 8000
Bulgaria
GC2202 Study Site 203
Plovdiv, 4000
Bulgaria
GC2202 Study Site 210
Plovdiv, 4003
Bulgaria
GC2202 Study Site 205
Rousse, 7000
Bulgaria
GC2202 Study Site 209
Sofia, 1142
Bulgaria
GC2202 Study Site 201
Sofia, 1431
Bulgaria
GC2202 Study Site 206
Sofia, 1606
Bulgaria
GC2202 Study Site 207
Sofia, 1612
Bulgaria
GC2202 Study Site 211
Sofia, 1618
Bulgaria
GC2202 Study Site 212
Sofia, 1750
Bulgaria
GC2202 Study Site 213
Sofia, 1756
Bulgaria
GC2202 Study Site 204
Sofia, 1797
Bulgaria
GC2202 Study Site 208
Sofia, 1797
Bulgaria
GC2202 Study Site 214
Stara Zagora, 6000
Bulgaria
GC2202 Study Site 801
Rijeka, 51000
Croatia
GC2202 Study Site 802
Zagreb, 10000
Croatia
GC2202 Study Site 305
Székesfehérvár, Fejér 8000
Hungary
GC2202 Study Site 301
Budapest, 1097
Hungary
GC2202 Study Site 308
Budapest, 1122
Hungary
GC2202 Study Site 306
Debrecen, 4032
Hungary
GC2202 Study Site 304
Eger, 3300
Hungary
GC2202 Study Site 302
Győr, 9024
Hungary
GC2202 Study Site 307
Szeged, 6725
Hungary
GC2202 Study Site 303
Szekszárd, 7110
Hungary
GC2202 Study Site 402
Torun, Kuyavian-Pomeranian Voivodeship 87-100
Poland
GC2202 Study Site 401
Krakow, Lesser Poland Voivodeship 30 688
Poland
GC2202 Study Site 401
Krakow, Lesser Poland Voivodeship 31-501
Poland
GC2202 Study Site 403
Legnica, Lower Silesian Voivodeship 59-220
Poland
GC2202 Study Site 406
Wałbrzych, Lower Silesian Voivodeship 58 309
Poland
GC2202 Study Site 406
Wałbrzych, Lower Silesian Voivodeship 58-309
Poland
GC2202 Study Site 405
Słupsk, Pomeranian Voivodeship 76-200
Poland
GC2202 Study Site 408
Bydgoszcz, 85-168
Poland
GC2202 Study Site 410
Krakow, 31-826
Poland
GC2202 Study Site 409
Olsztyn, 10-228
Poland
GC2202 Study Site 407
Torun, 87-100
Poland
GC2202 Study Site 511
Bucharest, Bucharest 022328
Romania
GC2202 Study Site 501
Bucharest, Bucharest 20125
Romania
GC2202 Study Site 503
Brasov, RO 500052
Romania
GC2202 Study Site 504
Bucharest, RO 30171
Romania
GC2202 Study Site 506
Cluj-Napoca, RO 400015
Romania
GC2202 Study Site 502
Timișoara, RO 300041
Romania
GC2202 Study Site 509
Bucharest, 022322
Romania
GC2202 Study Site 508
Bucharest, 050098
Romania
GC2202 Study Site 507
Constanța, 905900
Romania
GC2202 Study Site 510
Iași, 700483
Romania
GC2202 Study Site 602
Belgrade, 11000
Serbia
GC2202 Study Site 604
Belgrade, 11000
Serbia
GC2202 Study Site 605
Belgrade, 11080
Serbia
GC2202 Study Site 607
Belgrade, 11080
Serbia
GC2202 Study Site 603
Kamenitz, 21204
Serbia
GC2202 Study Site 601
Kragujevac, 34000
Serbia
GC2202 Study Site 606
Niš, 18000
Serbia