Phase
Condition
Leukemia
Bone Diseases
Platelet Disorders
Treatment
Placebo
Xembify
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 RAIstaging of intermediate (1 and 2) or high (3 and 4)
MM according to the International Myeloma Working Group criteria (IMWG), R-ISSstage 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 LuganoClassification.
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., ≥ 3infections) within 12 months before the screening visit. Severe bacterial/viralinfections ≥ Grade 3 (as defined by Common Terminology Criteria for Adverse Events [CTCAE] Grades).
Exclusion
Exclusion Criteria:
Participants with documented history of hematopoietic stem cell transplant.
Participants currently receiving immunoglobulin replacement therapy (IgRT) or havereceived IgG replacement treatment (i.e., prior immune globulin replacement therapy)within 6 months before the screening visit.
Participants with active infections at time of screening visit. Specific supportiveanti-infective prophylactic defined in the CLL National Comprehensive Cancer Network (NCCN) or iwCLL guidelines and/or local/international guidelines for the CLL, anddefined in local/international guidelines for MM and NHL are allowed, or recommendedin the updated labelling of specific active target disease medicines used during theparticipation in the trial is also allowed.
Participants with active second malignancies.
Participants with known primary immunodeficiency (PI).
Participants with a life expectancy less than 1.5 years.
Participants with clinical evidence of any significant acute or chronic diseasethat, in the opinion of the investigator, may interfere with successful completionof the trial or place the subject at undue medical risk.
Participants have had a known serious adverse reaction (AR) to immunoglobulin or anyanaphylactic reaction to blood or any blood-derived product.
Participants have a history of blistering skin disease, bleeding disorder, diffuserash, recurrent skin infections, or other disorders where SC therapy would becontraindicated during the study based upon the Investigator's discretion.
Participants have known Selective Immunoglobulin A (IgA) Deficiency (with or withoutantibodies to IgA) (Note: exclusion is for the specific diagnostic entity. It doesnot exclude other forms of humoral primary immunodeficiency which have decreased IgAin addition to decreased IgG requiring IgG replacement).
Participants with severe known kidney disease [as defined by estimated glomerularfiltration rate [eGFR] less than (<) 30 milliliter (mL)/min/1.73 squaremeter (m2)] as determined by the Principal Investigator.
Participants that have liver enzyme levels (alanine aminotransferase [ALT],aspartate aminotransferase [AST], gammaglutamyl transferase [GGT], or lactatedehydrogenase [LDH]) greater than 3 times the upper limit of normal (ULN) at theScreening Visit as defined by the testing laboratory.
Participants have a history (either 1 episode within the year prior to the ScreeningVisit or 2 previous episodes over a lifetime) of or current diagnosis ofthromboembolism (example, myocardial infarction, cerebrovascular accident, ortransient ischemic attack) or deep venous thrombosis.
Participants are currently receiving anti-coagulation therapy which would make SCadministration inadvisable (vitamin K antagonists, nonvitamin K antagonist oralanticoagulants [example, dabigatran etexilate targeting Factor IIa, rivaroxaban,edoxaban, and apixaban targeting Factor Xa], and parenteral anticoagulants [example,fondaparinux]).
Participants currently have a known hyperviscosity syndrome or hypercoagulablestates.
Participants have a known previous infection or clinical signs and symptomsconsistent with current hepatitis B virus or hepatitis C virus infection.
Participants with non-controlled arterial hypertension (systolic blood pressure [SBP] greater than 140 millimeters of mercury (mmHg) and/or diastolic blood pressure [DBP] greater than 90 mmHg), and/or a heart rate (HR) greater than100 bpm.
Participants with known substance or prescription drug abuse within 12 months beforethe Screening Visit.
Participants have participated in another clinical trial within 30 days prior toscreening (observational studies without investigative treatments [non-interventional] are permitted).
Study Design
Connect with a study center
GC2202 Study Site 702
Banja Luka, 780000
Bosnia and HerzegovinaActive - Recruiting
GC2202 Study Site 703
Mostar, 88000
Bosnia and HerzegovinaActive - Recruiting
GC2202 Study Site 701
Sarajevo, 71000
Bosnia and HerzegovinaActive - Recruiting
"University multiprofile hospital for active treatment - Burgas" AD, Internal diseases II level, clinical hematology I level
Burgas, 8000
BulgariaActive - Recruiting
GC2202 Study Site 202
Burgas, 8000
BulgariaActive - Recruiting
"Medical Center Leo Clinic" EOOD, consulting room 15
Plovdiv, 4003
BulgariaActive - Recruiting
GC2202 Study Site 203
Plovdiv, 4000
BulgariaActive - Recruiting
GC2202 Study Site 210
Plovdiv, 4003
BulgariaActive - Recruiting
"Complex oncology center - Ruse" EOOD, Department - medical oncology II level
Ruse, 7000
BulgariaActive - Recruiting
GC2202 Study Site 205
Ruse, 7000
BulgariaActive - Recruiting
"""Specialized Hospital for active treatment of hematological diseases"" EAD, First department clinical hematology to clinic on clinical hematology - clinical hematology III level"
Sofia, 1797
BulgariaActive - Recruiting
"Medical Center "Sirtuin"" Ltd, consulting room 7
Sofia, 1612
BulgariaActive - Recruiting
"Specialized Hospital for active treatment of hematological diseases" EAD, Second department clinical hematology to clinic on clinical hematology - clinical hematology III level
Sofia, 1797
BulgariaActive - Recruiting
"University First multiprofile hospital for active treatment - Sofia "St. Joan Krastitel"" EAD, Third Department of Internal Diseases
Sofia, 1142
BulgariaActive - Recruiting
"University multiprofile hospital for active treatment "Sv. Ivan Rilski"" EAD, Department of clinical hematology at Clinical Hematology Clinic - clinical hematology III level
Sofia, 1431
BulgariaActive - Recruiting
"University multiprofile hospital for active treatment and emergency medicine "N.I. Pirogov"" EAD, Internal diseases - internal diseases III level
Sofia, 1606
BulgariaActive - Recruiting
GC2202 Study Site 201
Sofia, 1431
BulgariaActive - Recruiting
GC2202 Study Site 204
Sofia, 1797
BulgariaActive - Recruiting
GC2202 Study Site 206
Sofia, 1606
BulgariaActive - Recruiting
GC2202 Study Site 207
Sofia, 1612
BulgariaActive - Recruiting
GC2202 Study Site 208
Sofia, 1797
BulgariaActive - Recruiting
GC2202 Study Site 209
Sofia, 1142
BulgariaActive - Recruiting
GC2202 Study Site 211
Sofia, 1618
BulgariaActive - Recruiting
GC2202 Study Site 212
Sofia, 1750
BulgariaActive - Recruiting
GC2202 Study Site 213
Sofia, 1756
BulgariaActive - Recruiting
GC2202 Study Site 214
Stara Zagora, 6000
BulgariaActive - Recruiting
GC2202 Study Site 305
Szekesfehervar, Fejer 8000
HungaryActive - Recruiting
GC2202 Study Site 301
Budapest, 1097
HungaryActive - Recruiting
GC2202 Study Site 308
Budapest, 1122
HungaryActive - Recruiting
GC2202 Study Site 306
Debrecen, 4032
HungaryActive - Recruiting
GC2202 Study Site 304
Eger, 3300
HungaryActive - Recruiting
GC2202 Study Site 302
Győr, 9024
HungaryActive - Recruiting
GC2202 Study Site 307
Szeged, 6725
HungaryActive - Recruiting
GC2202 Study Site 303
Szekszárd, 7110
HungaryActive - Recruiting
GC2202 Study Site 406
Walbrzych, Dolnoslaskie 58 309
PolandActive - Recruiting
GC2202 Study Site 403
Legnica, Dolnośląskie 59-220
PolandActive - Recruiting
Wojewodzki Szpital Specjalistyczny w Legnicy, Oddzial Hematologii
Legnica, Dolnośląskie 59-220
PolandActive - Recruiting
GC2202 Study Site 406
Wałbrzych, Dolnośląskie 58-309
PolandActive - Recruiting
Centrum Medyczne MICS Torun
Toruń, Kujawsko-pomorskie 87-100
PolandActive - Recruiting
GC2202 Study Site 402
Toruń, Kujawsko-pomorskie 87-100
PolandActive - Recruiting
GC2202 Study Site 401
Kraków, Malopolskie 30 688
PolandActive - Recruiting
GC2202 Study Site 405
Słupsk, Pomorskie 76-200
PolandActive - Recruiting
Wojewodzki Szpital Specjalistyczny imienia Janusza Korczaka w Slupsku Sp. z o.o., Oddzial Hematologii
Słupsk, Pomorskie 76-200
PolandActive - Recruiting
GC2202 Study Site 408
Bydgoszcz, 85-168
PolandActive - Recruiting
GC2202 Study Site 410
Kraków, 31-826
PolandActive - Recruiting
GC2202 Study Site 409
Olsztyn, 10-228
PolandActive - Recruiting
GC2202 Study Site 407
Toruń, 87-100
PolandActive - Recruiting
GC2202 Study Site 503
Brasov, RO 500052
RomaniaActive - Recruiting
Onco Card Srl
Brasov, RO 500052
RomaniaActive - Recruiting
GC2202 Study Site 504
Bucuresti, RO 30171
RomaniaActive - Recruiting
Spitalul Clinic Coltea
Bucuresti, RO 30171
RomaniaActive - Recruiting
GC2202 Study Site 506
Cluj-Napoca, RO 400015
RomaniaActive - Recruiting
IOCN
Cluj-Napoca, RO 400015
RomaniaActive - Recruiting
GC2202 Study Site 502
Timisoara, RO 300041
RomaniaActive - Recruiting
Spitalul Clinic Municipal de Urgenta Timisoara
Timisoara, RO 300041
RomaniaActive - Recruiting
GC2202 Study Site 501
Bucharest, 20125
RomaniaActive - Recruiting
GC2202 Study Site 508
Bucharest, 050098
RomaniaActive - Recruiting
GC2202 Study Site 509
Bucharest, 022322
RomaniaActive - Recruiting
GC2202 Study Site 507
Constanţa, 905900
RomaniaActive - Recruiting
GC2202 Study Site 510
Iaşi, 700483
RomaniaActive - Recruiting
GC2202 Study Site 604
Belgrad, 11000
SerbiaActive - Recruiting
"University Clinical Center of Serbia, Clinic of Hematology"
Belgrade, 11000
SerbiaActive - Recruiting
GC2202 Study Site 602
Belgrade, 11000
SerbiaActive - Recruiting
GC2202 Study Site 605
Belgrade, 11080
SerbiaActive - Recruiting
GC2202 Study Site 607
Belgrade, 11080
SerbiaActive - Recruiting
"University Clinical Center Kragujevac, Clinic of Hematology"
Kragujevac, 34000
SerbiaActive - Recruiting
GC2202 Study Site 601
Kragujevac, 34000
SerbiaActive - Recruiting
"University Clinical Center Nis, Clinic for Hematology, Alergology and Clinical Immunology "
Nis, 18000
SerbiaActive - Recruiting
GC2202 Study Site 606
Nis, 18000
SerbiaActive - Recruiting
"Oncology Institute of Vojvodina, Clinic for Internal Oncology "
Sremska Kamenica, 21204
SerbiaActive - Recruiting
GC2202 Study Site 603
Sremska Kamenica, 21204
SerbiaActive - Recruiting
GC2202 Study Site 107
Miami, Florida 33176
United StatesSite Not Available
JD Medical Group LLC
Miami, Florida 33176
United StatesActive - Recruiting
GC2202 Study Site 103
Saint Petersburg, Florida 33701
United StatesActive - Recruiting
GC2202 Study Site 109
Greenville, North Carolina 27843
United StatesActive - Recruiting
GC2202 Decentralized Study Site 114
Morrisville, North Carolina 27560
United StatesActive - Recruiting
GC2202 Study Site 105
Canton, Ohio 44718
United StatesActive - Recruiting
Gabrail Cancer and Research Center
Canton, Ohio 44718
United StatesActive - Recruiting
GC2202 Study Site 102
Columbus, Ohio 43235
United StatesSite Not Available
Optimed Research, LLC
Columbus, Ohio 43235
United StatesActive - Recruiting
Allergy and Clinical Immunology Associates
Pittsburgh, Pennsylvania 15241
United StatesActive - Recruiting
GC2202 Study Site 101
Pittsburgh, Pennsylvania 15241
United StatesSite Not Available
Carolina Blood and Cancer Care
Rockville, South Carolina 29732
United StatesActive - Recruiting
GC2202 Study Site 110
Rockville, South Carolina 29732
United StatesSite Not Available
GC2202 Study Site 108
Harlingen, Texas 78550
United StatesSite Not Available
Valley Cancer Associates
Harlingen, Texas 78550
United StatesActive - Recruiting
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