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

PHASE3RecruitingINTERVENTIONAL
Enrollment

386

Participants

Timeline

Start Date

December 26, 2022

Primary Completion Date

May 31, 2026

Study Completion Date

June 30, 2026

Conditions
HypogammaglobulinemiaBacterial InfectionsB-cell Chronic Lymphocytic LeukemiaMultiple MyleomaNon-Hodgkin Lymphoma
Interventions
DRUG

Xembify

SC infusion pump

DRUG

Placebo

SC infusion pump

Trial Locations (57)

1097

RECRUITING

GC2202 Study Site 301, Budapest

1122

RECRUITING

GC2202 Study Site 308, Budapest

1142

RECRUITING

GC2202 Study Site 209, Sofia

1431

RECRUITING

GC2202 Study Site 201, Sofia

1606

RECRUITING

GC2202 Study Site 206, Sofia

1612

RECRUITING

GC2202 Study Site 207, Sofia

1618

RECRUITING

GC2202 Study Site 211, Sofia

1750

RECRUITING

GC2202 Study Site 212, Sofia

1756

RECRUITING

GC2202 Study Site 213, Sofia

1797

RECRUITING

GC2202 Study Site 204, Sofia

RECRUITING

GC2202 Study Site 208, Sofia

3300

RECRUITING

GC2202 Study Site 304, Eger

4000

RECRUITING

GC2202 Study Site 203, Plovdiv

4003

RECRUITING

GC2202 Study Site 210, Plovdiv

4032

RECRUITING

GC2202 Study Site 306, Debrecen

6000

RECRUITING

GC2202 Study Site 214, Stara Zagora

6725

RECRUITING

GC2202 Study Site 307, Szeged

7000

RECRUITING

GC2202 Study Site 205, Rousse

7110

RECRUITING

GC2202 Study Site 303, Szekszárd

8000

RECRUITING

GC2202 Study Site 202, Burgas

RECRUITING

GC2202 Study Site 305, Székesfehérvár

9024

RECRUITING

GC2202 Study Site 302, Győr

11000

RECRUITING

GC2202 Study Site 602, Belgrade

RECRUITING

GC2202 Study Site 604, Belgrade

11080

RECRUITING

GC2202 Study Site 605, Belgrade

RECRUITING

GC2202 Study Site 607, Belgrade

18000

RECRUITING

GC2202 Study Site 606, Niš

20125

RECRUITING

GC2202 Study Site 501, Bucharest

21204

RECRUITING

GC2202 Study Site 603, Kamenitz

27560

RECRUITING

GC2202 Decentralized Study Site 114, Morrisville

27843

RECRUITING

GC2202 Study Site 109, Greenville

29732

WITHDRAWN

GC2202 Study Site 110, Rockville

30171

RECRUITING

GC2202 Study Site 504, Bucharest

33701

RECRUITING

GC2202 Study Site 103, St. Petersburg

34000

RECRUITING

GC2202 Study Site 601, Kragujevac

44718

RECRUITING

GC2202 Study Site 105, Canton

71000

RECRUITING

GC2202 Study Site 701, Sarajevo

88000

RECRUITING

GC2202 Study Site 703, Mostar

300041

RECRUITING

GC2202 Study Site 502, Timișoara

400015

RECRUITING

GC2202 Study Site 506, Cluj-Napoca

500052

RECRUITING

GC2202 Study Site 503, Brasov

700483

RECRUITING

GC2202 Study Site 510, Iași

780000

RECRUITING

GC2202 Study Site 702, Banja Luka

905900

RECRUITING

GC2202 Study Site 507, Constanța

87-100

RECRUITING

GC2202 Study Site 402, Torun

RECRUITING

GC2202 Study Site 407, Torun

30 688

RECRUITING

GC2202 Study Site 401, Krakow

31-501

RECRUITING

GC2202 Study Site 401, Krakow

59-220

RECRUITING

GC2202 Study Site 403, Legnica

58 309

RECRUITING

GC2202 Study Site 406, Wałbrzych

58-309

RECRUITING

GC2202 Study Site 406, Wałbrzych

76-200

RECRUITING

GC2202 Study Site 405, Słupsk

85-168

RECRUITING

GC2202 Study Site 408, Bydgoszcz

31-826

RECRUITING

GC2202 Study Site 410, Krakow

10-228

RECRUITING

GC2202 Study Site 409, Olsztyn

022322

RECRUITING

GC2202 Study Site 509, Bucharest

050098

RECRUITING

GC2202 Study Site 508, Bucharest

Sponsors
All Listed Sponsors
lead

Grifols Therapeutics LLC

INDUSTRY