Actively Recruiting
A Randomized, Double-Blinded Trial to Evaluate 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
Led by Grifols Therapeutics LLC · Updated on 2026-04-13
386
Participants Needed
62
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether biweekly doses of XEMBIFY4 combined with Standard Medical Treatment (SMT) over one year can reduce major bacterial infections in adults with hypogammaglobulinemia (HGG) linked to B-cell Chronic Lymphocytic Leukemia (CLL), Multiple Myeloma (MM), or Non-Hodgkin Lymphoma (NHL). The study compares this combination to placebo plus SMT in participants who have recurrent or severe infections and lower IgG levels. Participants are randomly assigned to receive either XEMBIFY or a placebo through subcutaneous infusion pumps. Both groups get a loading dose given daily for five days starting in Week 1, followed by biweekly infusions from Week 3 through Week 51. Throughout the study, all participants continue receiving their usual supportive medical treatments as part of SMT. During the year-long treatment phase, participants will be monitored for the rate of major bacterial infections as the main outcome. Additional assessments include the timing and frequency of infections, antibiotic use, and hospitalization details related to infections. Safety and pharmacokinetics are also evaluated, with follow-up visits scheduled regularly until the study ends in June 2026.
CONDITIONS
Brief 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 (CLL) with intermediate or high RAI staging, Multiple Myeloma (MM) with R-ISS stage II or III, or B-Cell Non-Hodgkin Lymphoma (NHL) Stage III or above
- Hypogammaglobulinemia with IgG levels less than 5 g/L (adjusted for MM patients)
- History of at least one severe bacterial or viral infection or three or more recurrent infections within 12 months before screening
You will not qualify if you...
- History of hematopoietic stem cell transplant within 24 months for allogenic or 3 months for autologous transplant
- Current or recent (within 6 months) immunoglobulin replacement therapy
- Active infections at screening visit (except as allowed by specific guidelines)
- Active second cancers
- Known primary immunodeficiency
- Life expectancy less than 1.5 years
- Significant acute or chronic diseases that may interfere with trial completion or increase risk
- Known serious adverse reaction to immunoglobulin or anaphylaxis to blood products
- History of blistering skin disease, bleeding disorder, recurrent skin infections, or conditions contraindicating subcutaneous therapy
- Known Selective Immunoglobulin A Deficiency
- Severe kidney disease with eGFR less than 30 mL/min/1.73 m2
- Liver enzyme levels over three times the upper limit of normal
- History or current diagnosis of thromboembolism or deep venous thrombosis
- Known hyperviscosity syndrome or hypercoagulable states
- Current or past hepatitis B or C infection
- Uncontrolled high blood pressure 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 (except non-interventional studies)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 51 weeks
Participants receive either XEMBIFY or placebo infusions along with standard medical treatment to prevent infections.
5 daily visits in Week 1 followed by biweekly visits starting Week 3 through Week 51
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
M
Marina Acosta Enslen
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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