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

Last updated: April 9, 2025
Sponsor: Grifols Therapeutics LLC
Overall Status: Active - Recruiting

Phase

3

Condition

Leukemia

Bone Diseases

Platelet Disorders

Treatment

Placebo

Xembify

Clinical Study ID

NCT05645107
GC2202
XEMBIFY® - CLL, MM, and NHL
XEMBIFY® - CLL
2022-502193-16-00
  • Ages > 18
  • All Genders

Study 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 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

Total Participants: 386
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
December 26, 2022
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • GC2202 Study Site 702

    Banja Luka, 780000
    Bosnia and Herzegovina

    Active - Recruiting

  • GC2202 Study Site 703

    Mostar, 88000
    Bosnia and Herzegovina

    Active - Recruiting

  • GC2202 Study Site 701

    Sarajevo, 71000
    Bosnia and Herzegovina

    Active - Recruiting

  • "University multiprofile hospital for active treatment - Burgas" AD, Internal diseases II level, clinical hematology I level

    Burgas, 8000
    Bulgaria

    Active - Recruiting

  • GC2202 Study Site 202

    Burgas, 8000
    Bulgaria

    Active - Recruiting

  • "Medical Center Leo Clinic" EOOD, consulting room 15

    Plovdiv, 4003
    Bulgaria

    Active - Recruiting

  • GC2202 Study Site 203

    Plovdiv, 4000
    Bulgaria

    Active - Recruiting

  • GC2202 Study Site 210

    Plovdiv, 4003
    Bulgaria

    Active - Recruiting

  • "Complex oncology center - Ruse" EOOD, Department - medical oncology II level

    Ruse, 7000
    Bulgaria

    Active - Recruiting

  • GC2202 Study Site 205

    Ruse, 7000
    Bulgaria

    Active - 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
    Bulgaria

    Active - Recruiting

  • "Medical Center "Sirtuin"" Ltd, consulting room 7

    Sofia, 1612
    Bulgaria

    Active - 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
    Bulgaria

    Active - Recruiting

  • "University First multiprofile hospital for active treatment - Sofia "St. Joan Krastitel"" EAD, Third Department of Internal Diseases

    Sofia, 1142
    Bulgaria

    Active - 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
    Bulgaria

    Active - Recruiting

  • "University multiprofile hospital for active treatment and emergency medicine "N.I. Pirogov"" EAD, Internal diseases - internal diseases III level

    Sofia, 1606
    Bulgaria

    Active - Recruiting

  • GC2202 Study Site 201

    Sofia, 1431
    Bulgaria

    Active - Recruiting

  • GC2202 Study Site 204

    Sofia, 1797
    Bulgaria

    Active - Recruiting

  • GC2202 Study Site 206

    Sofia, 1606
    Bulgaria

    Active - Recruiting

  • GC2202 Study Site 207

    Sofia, 1612
    Bulgaria

    Active - Recruiting

  • GC2202 Study Site 208

    Sofia, 1797
    Bulgaria

    Active - Recruiting

  • GC2202 Study Site 209

    Sofia, 1142
    Bulgaria

    Active - Recruiting

  • GC2202 Study Site 211

    Sofia, 1618
    Bulgaria

    Active - Recruiting

  • GC2202 Study Site 212

    Sofia, 1750
    Bulgaria

    Active - Recruiting

  • GC2202 Study Site 213

    Sofia, 1756
    Bulgaria

    Active - Recruiting

  • GC2202 Study Site 214

    Stara Zagora, 6000
    Bulgaria

    Active - Recruiting

  • GC2202 Study Site 305

    Szekesfehervar, Fejer 8000
    Hungary

    Active - Recruiting

  • GC2202 Study Site 301

    Budapest, 1097
    Hungary

    Active - Recruiting

  • GC2202 Study Site 308

    Budapest, 1122
    Hungary

    Active - Recruiting

  • GC2202 Study Site 306

    Debrecen, 4032
    Hungary

    Active - Recruiting

  • GC2202 Study Site 304

    Eger, 3300
    Hungary

    Active - Recruiting

  • GC2202 Study Site 302

    Győr, 9024
    Hungary

    Active - Recruiting

  • GC2202 Study Site 307

    Szeged, 6725
    Hungary

    Active - Recruiting

  • GC2202 Study Site 303

    Szekszárd, 7110
    Hungary

    Active - Recruiting

  • GC2202 Study Site 406

    Walbrzych, Dolnoslaskie 58 309
    Poland

    Active - Recruiting

  • GC2202 Study Site 403

    Legnica, Dolnośląskie 59-220
    Poland

    Active - Recruiting

  • Wojewodzki Szpital Specjalistyczny w Legnicy, Oddzial Hematologii

    Legnica, Dolnośląskie 59-220
    Poland

    Active - Recruiting

  • GC2202 Study Site 406

    Wałbrzych, Dolnośląskie 58-309
    Poland

    Active - Recruiting

  • Centrum Medyczne MICS Torun

    Toruń, Kujawsko-pomorskie 87-100
    Poland

    Active - Recruiting

  • GC2202 Study Site 402

    Toruń, Kujawsko-pomorskie 87-100
    Poland

    Active - Recruiting

  • GC2202 Study Site 401

    Kraków, Malopolskie 30 688
    Poland

    Active - Recruiting

  • GC2202 Study Site 405

    Słupsk, Pomorskie 76-200
    Poland

    Active - Recruiting

  • Wojewodzki Szpital Specjalistyczny imienia Janusza Korczaka w Slupsku Sp. z o.o., Oddzial Hematologii

    Słupsk, Pomorskie 76-200
    Poland

    Active - Recruiting

  • GC2202 Study Site 408

    Bydgoszcz, 85-168
    Poland

    Active - Recruiting

  • GC2202 Study Site 410

    Kraków, 31-826
    Poland

    Active - Recruiting

  • GC2202 Study Site 409

    Olsztyn, 10-228
    Poland

    Active - Recruiting

  • GC2202 Study Site 407

    Toruń, 87-100
    Poland

    Active - Recruiting

  • GC2202 Study Site 503

    Brasov, RO 500052
    Romania

    Active - Recruiting

  • Onco Card Srl

    Brasov, RO 500052
    Romania

    Active - Recruiting

  • GC2202 Study Site 504

    Bucuresti, RO 30171
    Romania

    Active - Recruiting

  • Spitalul Clinic Coltea

    Bucuresti, RO 30171
    Romania

    Active - Recruiting

  • GC2202 Study Site 506

    Cluj-Napoca, RO 400015
    Romania

    Active - Recruiting

  • IOCN

    Cluj-Napoca, RO 400015
    Romania

    Active - Recruiting

  • GC2202 Study Site 502

    Timisoara, RO 300041
    Romania

    Active - Recruiting

  • Spitalul Clinic Municipal de Urgenta Timisoara

    Timisoara, RO 300041
    Romania

    Active - Recruiting

  • GC2202 Study Site 501

    Bucharest, 20125
    Romania

    Active - Recruiting

  • GC2202 Study Site 508

    Bucharest, 050098
    Romania

    Active - Recruiting

  • GC2202 Study Site 509

    Bucharest, 022322
    Romania

    Active - Recruiting

  • GC2202 Study Site 507

    Constanţa, 905900
    Romania

    Active - Recruiting

  • GC2202 Study Site 510

    Iaşi, 700483
    Romania

    Active - Recruiting

  • GC2202 Study Site 604

    Belgrad, 11000
    Serbia

    Active - Recruiting

  • "University Clinical Center of Serbia, Clinic of Hematology"

    Belgrade, 11000
    Serbia

    Active - Recruiting

  • GC2202 Study Site 602

    Belgrade, 11000
    Serbia

    Active - Recruiting

  • GC2202 Study Site 605

    Belgrade, 11080
    Serbia

    Active - Recruiting

  • GC2202 Study Site 607

    Belgrade, 11080
    Serbia

    Active - Recruiting

  • "University Clinical Center Kragujevac, Clinic of Hematology"

    Kragujevac, 34000
    Serbia

    Active - Recruiting

  • GC2202 Study Site 601

    Kragujevac, 34000
    Serbia

    Active - Recruiting

  • "University Clinical Center Nis, Clinic for Hematology, Alergology and Clinical Immunology "

    Nis, 18000
    Serbia

    Active - Recruiting

  • GC2202 Study Site 606

    Nis, 18000
    Serbia

    Active - Recruiting

  • "Oncology Institute of Vojvodina, Clinic for Internal Oncology "

    Sremska Kamenica, 21204
    Serbia

    Active - Recruiting

  • GC2202 Study Site 603

    Sremska Kamenica, 21204
    Serbia

    Active - Recruiting

  • GC2202 Study Site 107

    Miami, Florida 33176
    United States

    Site Not Available

  • JD Medical Group LLC

    Miami, Florida 33176
    United States

    Active - Recruiting

  • GC2202 Study Site 103

    Saint Petersburg, Florida 33701
    United States

    Active - Recruiting

  • GC2202 Study Site 109

    Greenville, North Carolina 27843
    United States

    Active - Recruiting

  • GC2202 Decentralized Study Site 114

    Morrisville, North Carolina 27560
    United States

    Active - Recruiting

  • GC2202 Study Site 105

    Canton, Ohio 44718
    United States

    Active - Recruiting

  • Gabrail Cancer and Research Center

    Canton, Ohio 44718
    United States

    Active - Recruiting

  • GC2202 Study Site 102

    Columbus, Ohio 43235
    United States

    Site Not Available

  • Optimed Research, LLC

    Columbus, Ohio 43235
    United States

    Active - Recruiting

  • Allergy and Clinical Immunology Associates

    Pittsburgh, Pennsylvania 15241
    United States

    Active - Recruiting

  • GC2202 Study Site 101

    Pittsburgh, Pennsylvania 15241
    United States

    Site Not Available

  • Carolina Blood and Cancer Care

    Rockville, South Carolina 29732
    United States

    Active - Recruiting

  • GC2202 Study Site 110

    Rockville, South Carolina 29732
    United States

    Site Not Available

  • GC2202 Study Site 108

    Harlingen, Texas 78550
    United States

    Site Not Available

  • Valley Cancer Associates

    Harlingen, Texas 78550
    United States

    Active - Recruiting

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