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

Status: Recruiting
Location: See all (60) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Participants ≥18 years of age at screening visit

• Participants with documented and confirmed diagnosis of any of the below diseases:

‣ B-cell CLL according to International Workshop on CLL (iwCLL) criteria and RAI staging of intermediate (1 and 2) or high (3 and 4)

⁃ MM according to the International Myeloma Working Group criteria (IMWG), R-ISS stage II or, III; or

⁃ Histologically confirmed diagnosis of B-Cell NHL, Stage III or above (IV, Progressive/refractory, or recurrent/relapsed stage) according to the Lugano Classification.

• Participants with HGG with IgG levels less than 5 g/L.

• Participants with documented history of at least one severe bacterial infection (bacterial or viral) or recurrent bacterial/viral infections (that is., ≥ 3 infections) within 12 months before the screening visit. Severe bacterial/viral infections ≥ Grade 3 (as defined by Common Terminology Criteria for Adverse Events \[CTCAE\] Grades).

Locations
United States
Florida
GC2202 Study Site 103
RECRUITING
St. Petersburg
Maryland
GC2202 Study Site 111
RECRUITING
Bethesda
North Carolina
GC2202 Study Site 109
RECRUITING
Greenville
GC2202 Decentralized Study Site 114
RECRUITING
Morrisville
Ohio
GC2202 Study Site 105
RECRUITING
Canton
South Carolina
GC2202 Study Site 110
WITHDRAWN
Rockville
Other Locations
Bosnia and Herzegovina
GC2202 Study Site 702
RECRUITING
Banja Luka
GC2202 Study Site 703
RECRUITING
Mostar
GC2202 Study Site 701
NOT_YET_RECRUITING
Sarajevo
Bulgaria
GC2202 Study Site 202
RECRUITING
Burgas
GC2202 Study Site 203
RECRUITING
Plovdiv
GC2202 Study Site 210
RECRUITING
Plovdiv
GC2202 Study Site 205
RECRUITING
Rousse
GC2202 Study Site 201
RECRUITING
Sofia
GC2202 Study Site 204
RECRUITING
Sofia
GC2202 Study Site 206
RECRUITING
Sofia
GC2202 Study Site 207
RECRUITING
Sofia
GC2202 Study Site 208
RECRUITING
Sofia
GC2202 Study Site 209
RECRUITING
Sofia
GC2202 Study Site 211
RECRUITING
Sofia
GC2202 Study Site 212
RECRUITING
Sofia
GC2202 Study Site 213
RECRUITING
Sofia
GC2202 Study Site 214
RECRUITING
Stara Zagora
Croatia
GC2202 Study Site 801
RECRUITING
Rijeka
GC2202 Study Site 802
RECRUITING
Zagreb
Hungary
GC2202 Study Site 301
RECRUITING
Budapest
GC2202 Study Site 308
RECRUITING
Budapest
GC2202 Study Site 306
RECRUITING
Debrecen
GC2202 Study Site 304
RECRUITING
Eger
GC2202 Study Site 302
RECRUITING
Győr
GC2202 Study Site 307
RECRUITING
Szeged
GC2202 Study Site 305
WITHDRAWN
Székesfehérvár
GC2202 Study Site 303
RECRUITING
Szekszárd
Poland
GC2202 Study Site 408
NOT_YET_RECRUITING
Bydgoszcz
GC2202 Study Site 401
RECRUITING
Krakow
GC2202 Study Site 401
RECRUITING
Krakow
GC2202 Study Site 410
NOT_YET_RECRUITING
Krakow
GC2202 Study Site 403
RECRUITING
Legnica
GC2202 Study Site 409
NOT_YET_RECRUITING
Olsztyn
GC2202 Study Site 405
RECRUITING
Słupsk
GC2202 Study Site 402
RECRUITING
Torun
GC2202 Study Site 407
NOT_YET_RECRUITING
Torun
GC2202 Study Site 406
RECRUITING
Wałbrzych
Romania
GC2202 Study Site 503
RECRUITING
Brasov
GC2202 Study Site 501
RECRUITING
Bucharest
GC2202 Study Site 504
RECRUITING
Bucharest
GC2202 Study Site 508
RECRUITING
Bucharest
GC2202 Study Site 509
RECRUITING
Bucharest
GC2202 Study Site 511
RECRUITING
Bucharest
GC2202 Study Site 506
RECRUITING
Cluj-napoca
GC2202 Study Site 507
RECRUITING
Constanța
GC2202 Study Site 510
RECRUITING
Iași
GC2202 Study Site 502
RECRUITING
Timișoara
Serbia
GC2202 Study Site 602
RECRUITING
Belgrade
GC2202 Study Site 604
RECRUITING
Belgrade
GC2202 Study Site 605
WITHDRAWN
Belgrade
GC2202 Study Site 607
RECRUITING
Belgrade
GC2202 Study Site 603
RECRUITING
Kamenitz
GC2202 Study Site 601
RECRUITING
Kragujevac
GC2202 Study Site 606
RECRUITING
Niš
Contact Information
Primary
Terra Mao
terra.mao@grifols.com
+1 9195649275
Backup
Marina Acosta Enslen
marina.acostaenslen@grifols.com
Time Frame
Start Date: 2022-12-26
Estimated Completion Date: 2026-06
Participants
Target number of participants: 386
Treatments
Experimental: XEMBIFY + Standard Medical Treatment (SMT)
Participants will receive a loading dose of 150 milligrams per kilograms per day (mg/kg/day) (Week 1, Days 1 to 5) subcutaneously (SC) for 5 consecutive daily doses followed by biweekly infusions of 300 mg/kg/2-week starting Week 3 (Day 15) through Week 51 (end of Treatment Phase).~The SMT will include the active treatments and the other supportive treatments that the participants will need during their participation.
Placebo_comparator: Placebo + SMT
Participants will receive sterile 0.9 percent Sodium Chloride Injection (commercially available in the corresponding country) starting at Week 1 (Days 1 to 5) SC for 5 consecutive daily doses followed by biweekly infusions starting at Week 3 (Day 15) through Week 51.~The SMT will include the active treatments and the other supportive treatments that the participants will need during their participation.
Sponsors
Leads: Grifols Therapeutics LLC

This content was sourced from clinicaltrials.gov

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