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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
Sponsor: Grifols Therapeutics LLC
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.
Official title: A Randomized, Multi-Center, Parallel, Double-Blinded, Placebo-Controlled Clinical Trial to Evaluate Efficacy, Safety, and Pharmacokinetics of XEMBIFY® Plus Standard Medical Treatment Compared to Placebo Plus Standard Medical Treatment to Prevent Infections in Patients With Hypogammaglobulinemia and Recurrent or Severe Infections Associated With B-cell Chronic Lymphocytic Leukemia, Multiple Myeloma, and Non-Hodgkin Lymphoma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
386
Start Date
2022-12-26
Completion Date
2026-06
Last Updated
2025-12-16
Healthy Volunteers
No
Conditions
Interventions
Xembify
SC infusion pump
Placebo
SC infusion pump
Locations (61)
GC2202 Study Site 103
St. Petersburg, Florida, United States
GC2202 Study Site 111
Bethesda, Maryland, United States
GC2202 Study Site 109
Greenville, North Carolina, United States
GC2202 Decentralized Study Site 114
Morrisville, North Carolina, United States
GC2202 Study Site 105
Canton, Ohio, United States
GC2202 Study Site 110
Rockville, South Carolina, United States
GC2202 Study Site 702
Banja Luka, Bosnia and Herzegovina
GC2202 Study Site 703
Mostar, Bosnia and Herzegovina
GC2202 Study Site 701
Sarajevo, Bosnia and Herzegovina
GC2202 Study Site 202
Burgas, Bulgaria
GC2202 Study Site 203
Plovdiv, Bulgaria
GC2202 Study Site 210
Plovdiv, Bulgaria
GC2202 Study Site 205
Rousse, Bulgaria
GC2202 Study Site 209
Sofia, Bulgaria
GC2202 Study Site 201
Sofia, Bulgaria
GC2202 Study Site 206
Sofia, Bulgaria
GC2202 Study Site 207
Sofia, Bulgaria
GC2202 Study Site 211
Sofia, Bulgaria
GC2202 Study Site 212
Sofia, Bulgaria
GC2202 Study Site 213
Sofia, Bulgaria
GC2202 Study Site 204
Sofia, Bulgaria
GC2202 Study Site 208
Sofia, Bulgaria
GC2202 Study Site 214
Stara Zagora, Bulgaria
GC2202 Study Site 801
Rijeka, Croatia
GC2202 Study Site 802
Zagreb, Croatia
GC2202 Study Site 305
Székesfehérvár, Fejér, Hungary
GC2202 Study Site 301
Budapest, Hungary
GC2202 Study Site 308
Budapest, Hungary
GC2202 Study Site 306
Debrecen, Hungary
GC2202 Study Site 304
Eger, Hungary
GC2202 Study Site 302
Győr, Hungary
GC2202 Study Site 307
Szeged, Hungary
GC2202 Study Site 303
Szekszárd, Hungary
GC2202 Study Site 402
Torun, Kuyavian-Pomeranian Voivodeship, Poland
GC2202 Study Site 401
Krakow, Lesser Poland Voivodeship, Poland
GC2202 Study Site 401
Krakow, Lesser Poland Voivodeship, Poland
GC2202 Study Site 403
Legnica, Lower Silesian Voivodeship, Poland
GC2202 Study Site 406
Wałbrzych, Lower Silesian Voivodeship, Poland
GC2202 Study Site 406
Wałbrzych, Lower Silesian Voivodeship, Poland
GC2202 Study Site 405
Słupsk, Pomeranian Voivodeship, Poland
GC2202 Study Site 408
Bydgoszcz, Poland
GC2202 Study Site 410
Krakow, Poland
GC2202 Study Site 409
Olsztyn, Poland
GC2202 Study Site 407
Torun, Poland
GC2202 Study Site 503
Brasov, RO, Romania
GC2202 Study Site 504
Bucharest, RO, Romania
GC2202 Study Site 506
Cluj-Napoca, RO, Romania
GC2202 Study Site 502
Timișoara, RO, Romania
GC2202 Study Site 509
Bucharest, Romania
GC2202 Study Site 511
Bucharest, Romania
GC2202 Study Site 508
Bucharest, Romania
GC2202 Study Site 501
Bucharest, Romania
GC2202 Study Site 507
Constanța, Romania
GC2202 Study Site 510
Iași, Romania
GC2202 Study Site 602
Belgrade, Serbia
GC2202 Study Site 604
Belgrade, Serbia
GC2202 Study Site 605
Belgrade, Serbia
GC2202 Study Site 607
Belgrade, Serbia
GC2202 Study Site 603
Kamenitz, Serbia
GC2202 Study Site 601
Kragujevac, Serbia
GC2202 Study Site 606
Niš, Serbia