Actively Recruiting
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
Led by Grifols Therapeutics LLC · Updated on 2026-04-13
386
Participants Needed
62
Research Sites
179 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants 18 years of age or older at screening
- Diagnosed with B-cell Chronic Lymphocytic Leukemia (RAI stage 1-4), Multiple Myeloma (R-ISS stage II or III), or B-cell Non-Hodgkin Lymphoma (stage III or above)
- Hypogammaglobulinemia with IgG levels less than 5 g/L (adjusted for M-protein in Multiple Myeloma)
- History of at least one severe bacterial or viral infection or three or more infections within 12 months before screening, with infections graded 3 or higher
You will not qualify if you...
- History of hematopoietic stem cell transplant within 24 months for allogenic or 3 months for autologous before screening
- Receiving or received immunoglobulin replacement therapy within 6 months before screening
- Active infections at screening (except those allowed by specified clinical guidelines)
- Presence of active second malignancies
- Known primary immunodeficiency
- Life expectancy less than 1.5 years
- Significant acute or chronic disease interfering with trial completion or causing undue risk
- History of serious adverse reactions or anaphylaxis to immunoglobulin or blood products
- History of blistering skin disease, bleeding disorders, diffuse rash, recurrent skin infections, or other contraindications to subcutaneous therapy
- Known Selective Immunoglobulin A (IgA) Deficiency
- Severe kidney disease with eGFR less than 30 mL/min/1.73 m2
- Liver enzyme levels greater than 3 times the upper limit of normal
- History or current diagnosis of thromboembolism or deep venous thrombosis
- Known hyperviscosity syndrome or hypercoagulable states
- Previous or current hepatitis B or C infection
- Non-controlled arterial hypertension (SBP >140 mmHg and/or DBP >90 mmHg) or heart rate over 100 bpm
- Substance or prescription drug abuse within 12 months before screening
- Participation in another clinical trial within 30 days before screening (non-interventional studies allowed)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 62 locations
1
GC2202 Study Site 115
Huntington Park, California, United States, 90255
Actively Recruiting
2
GC2202 Study Site 103
St. Petersburg, Florida, United States, 33701
Actively Recruiting
3
GC2202 Study Site 111
Bethesda, Maryland, United States, 20889
Actively Recruiting
4
GC2202 Study Site 109
Greenville, North Carolina, United States, 27843
Actively Recruiting
5
GC2202 Decentralized Study Site 114
Morrisville, North Carolina, United States, 27560
Actively Recruiting
6
GC2202 Study Site 105
Canton, Ohio, United States, 44718
Actively Recruiting
7
GC2202 Study Site 110
Rockville, South Carolina, United States, 29732
Withdrawn
8
GC2202 Study Site 702
Banja Luka, Bosnia and Herzegovina, 780000
Actively Recruiting
9
GC2202 Study Site 703
Mostar, Bosnia and Herzegovina, 88000
Actively Recruiting
10
GC2202 Study Site 701
Sarajevo, Bosnia and Herzegovina, 71000
Not Yet Recruiting
11
GC2202 Study Site 202
Burgas, Bulgaria, 8000
Actively Recruiting
12
GC2202 Study Site 203
Plovdiv, Bulgaria, 4000
Actively Recruiting
13
GC2202 Study Site 210
Plovdiv, Bulgaria, 4003
Actively Recruiting
14
GC2202 Study Site 205
Rousse, Bulgaria, 7000
Actively Recruiting
15
GC2202 Study Site 209
Sofia, Bulgaria, 1142
Actively Recruiting
16
GC2202 Study Site 201
Sofia, Bulgaria, 1431
Actively Recruiting
17
GC2202 Study Site 206
Sofia, Bulgaria, 1606
Actively Recruiting
18
GC2202 Study Site 207
Sofia, Bulgaria, 1612
Actively Recruiting
19
GC2202 Study Site 211
Sofia, Bulgaria, 1618
Actively Recruiting
20
GC2202 Study Site 212
Sofia, Bulgaria, 1750
Actively Recruiting
21
GC2202 Study Site 213
Sofia, Bulgaria, 1756
Actively Recruiting
22
GC2202 Study Site 204
Sofia, Bulgaria, 1797
Actively Recruiting
23
GC2202 Study Site 208
Sofia, Bulgaria, 1797
Actively Recruiting
24
GC2202 Study Site 214
Stara Zagora, Bulgaria, 6000
Actively Recruiting
25
GC2202 Study Site 801
Rijeka, Croatia, 51000
Actively Recruiting
26
GC2202 Study Site 802
Zagreb, Croatia, 10000
Actively Recruiting
27
GC2202 Study Site 305
Székesfehérvár, Fejér, Hungary, 8000
Withdrawn
28
GC2202 Study Site 301
Budapest, Hungary, 1097
Actively Recruiting
29
GC2202 Study Site 308
Budapest, Hungary, 1122
Actively Recruiting
30
GC2202 Study Site 306
Debrecen, Hungary, 4032
Actively Recruiting
31
GC2202 Study Site 304
Eger, Hungary, 3300
Actively Recruiting
32
GC2202 Study Site 302
Győr, Hungary, 9024
Actively Recruiting
33
GC2202 Study Site 307
Szeged, Hungary, 6725
Actively Recruiting
34
GC2202 Study Site 303
Szekszárd, Hungary, 7110
Actively Recruiting
35
GC2202 Study Site 402
Torun, Kuyavian-Pomeranian Voivodeship, Poland, 87-100
Actively Recruiting
36
GC2202 Study Site 401
Krakow, Lesser Poland Voivodeship, Poland, 30 688
Actively Recruiting
37
GC2202 Study Site 401
Krakow, Lesser Poland Voivodeship, Poland, 31-501
Actively Recruiting
38
GC2202 Study Site 403
Legnica, Lower Silesian Voivodeship, Poland, 59-220
Actively Recruiting
39
GC2202 Study Site 406
Wałbrzych, Lower Silesian Voivodeship, Poland, 58 309
Actively Recruiting
40
GC2202 Study Site 406
Wałbrzych, Lower Silesian Voivodeship, Poland, 58-309
Actively Recruiting
41
GC2202 Study Site 405
Słupsk, Pomeranian Voivodeship, Poland, 76-200
Actively Recruiting
42
GC2202 Study Site 408
Bydgoszcz, Poland, 85-168
Actively Recruiting
43
GC2202 Study Site 410
Krakow, Poland, 31-826
Not Yet Recruiting
44
GC2202 Study Site 409
Olsztyn, Poland, 10-228
Actively Recruiting
45
GC2202 Study Site 407
Torun, Poland, 87-100
Not Yet Recruiting
46
GC2202 Study Site 511
Bucharest, Bucharest, Romania, 022328
Actively Recruiting
47
GC2202 Study Site 501
Bucharest, Bucharest, Romania, 20125
Actively Recruiting
48
GC2202 Study Site 503
Brasov, RO, Romania, 500052
Actively Recruiting
49
GC2202 Study Site 504
Bucharest, RO, Romania, 30171
Actively Recruiting
50
GC2202 Study Site 506
Cluj-Napoca, RO, Romania, 400015
Actively Recruiting
51
GC2202 Study Site 502
Timișoara, RO, Romania, 300041
Actively Recruiting
52
GC2202 Study Site 509
Bucharest, Romania, 022322
Actively Recruiting
53
GC2202 Study Site 508
Bucharest, Romania, 050098
Actively Recruiting
54
GC2202 Study Site 507
Constanța, Romania, 905900
Actively Recruiting
55
GC2202 Study Site 510
Iași, Romania, 700483
Actively Recruiting
56
GC2202 Study Site 602
Belgrade, Serbia, 11000
Actively Recruiting
57
GC2202 Study Site 604
Belgrade, Serbia, 11000
Actively Recruiting
58
GC2202 Study Site 605
Belgrade, Serbia, 11080
Withdrawn
59
GC2202 Study Site 607
Belgrade, Serbia, 11080
Actively Recruiting
60
GC2202 Study Site 603
Kamenitz, Serbia, 21204
Actively Recruiting
61
GC2202 Study Site 601
Kragujevac, Serbia, 34000
Actively Recruiting
62
GC2202 Study Site 606
Niš, Serbia, 18000
Actively Recruiting
Research Team
K
Karen Pellath
CONTACT
M
Marina Acosta Enslen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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