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NCT05645107PHASE3Recruiting

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

Grifols Therapeutics LLC

Start Date

12/26/2022

Completion Date

8/1/2029

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

Age Range: 18 years to No maximum

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 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. (Note: For MM subjects, the IgG level is adjusted by subtracting the M-protein \[Mspike\] to reflect the true polyclonal IgG concentration.) * 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). Exclusion Criteria: * Participants with documented history of hematopoietic stem cell transplant (allogenic transplant in the previous 24 months, and autologous transplant in the previous 3 months) before Screening visit. * Participants currently receiving immunoglobulin replacement therapy (IgRT) or have received 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 supportive anti-infective prophylactic defined in the CLL National Comprehensive Cancer Network (NCCN) or iwCLL guidelines and/or local/international guidelines for the CLL, and defined in local/international guidelines for MM and NHL are allowed, or recommended in the updated labelling of specific active target disease medicines used during the participation 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 disease that, in the opinion of the investigator, may interfere with successful completion of the trial or place the subject at undue medical risk. * Participants have had a known serious adverse reaction (AR) to immunoglobulin or any anaphylactic reaction to blood or any blood-derived product. * Participants have a history of blistering skin disease, bleeding disorder, diffuse rash, recurrent skin infections, or other disorders where SC therapy would be contraindicated during the study based upon the Investigator's discretion. * Participants have known Selective Immunoglobulin A (IgA) Deficiency (with or without antibodies to IgA) (Note: exclusion is for the specific diagnostic entity. It does not exclude other forms of humoral primary immunodeficiency which have decreased IgA in addition to decreased IgG requiring IgG replacement). * Participants with severe known kidney disease \[as defined by estimated glomerular filtration rate \[eGFR\] less than (\<) 30 milliliter (mL)/min/1.73 square meter (m2)\] as determined by the Principal Investigator. * Participants that have liver enzyme levels (alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], gammaglutamyl transferase \[GGT\], or lactate dehydrogenase \[LDH\]) greater than 3 times the upper limit of normal (ULN) at the Screening Visit as defined by the testing laboratory. * Participants have a history (either 1 episode within the year prior to the Screening Visit or 2 previous episodes over a lifetime) of or current diagnosis of thromboembolism (example, myocardial infarction, cerebrovascular accident, or transient ischemic attack) or deep venous thrombosis. * Participants currently have a known hyperviscosity syndrome or hypercoagulable states. * Participants have a known previous infection or clinical signs and symptoms consistent 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 before the Screening Visit. * Participants have participated in another clinical trial within 30 days prior to screening (observational studies without investigative treatments \[non-interventional\] are permitted).

Interventions

DRUG

Xembify

DRUG

Placebo

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Conditions

HypogammaglobulinemiaBacterial InfectionsB-cell Chronic Lymphocytic LeukemiaMultiple MyleomaNon-Hodgkin Lymphoma

Locations

GC2202 Study Site 115

Huntington Park, California 90255

United States

GC2202 Study Site 103

St. Petersburg, Florida 33701

United States

GC2202 Study Site 111

Bethesda, Maryland 20889

United States

GC2202 Study Site 109

Greenville, North Carolina 27843

United States

GC2202 Decentralized Study Site 114

Morrisville, North Carolina 27560

United States

GC2202 Study Site 105

Canton, Ohio 44718

United States

GC2202 Study Site 110

Rockville, South Carolina 29732

United States

GC2202 Study Site 702

Banja Luka, 780000

Bosnia and Herzegovina

GC2202 Study Site 703

Mostar, 88000

Bosnia and Herzegovina

GC2202 Study Site 701

Sarajevo, 71000

Bosnia and Herzegovina

GC2202 Study Site 202

Burgas, 8000

Bulgaria

GC2202 Study Site 203

Plovdiv, 4000

Bulgaria

GC2202 Study Site 210

Plovdiv, 4003

Bulgaria

GC2202 Study Site 205

Rousse, 7000

Bulgaria

GC2202 Study Site 209

Sofia, 1142

Bulgaria

GC2202 Study Site 201

Sofia, 1431

Bulgaria

GC2202 Study Site 206

Sofia, 1606

Bulgaria

GC2202 Study Site 207

Sofia, 1612

Bulgaria

GC2202 Study Site 211

Sofia, 1618

Bulgaria

GC2202 Study Site 212

Sofia, 1750

Bulgaria

GC2202 Study Site 213

Sofia, 1756

Bulgaria

GC2202 Study Site 204

Sofia, 1797

Bulgaria

GC2202 Study Site 208

Sofia, 1797

Bulgaria

GC2202 Study Site 214

Stara Zagora, 6000

Bulgaria

GC2202 Study Site 801

Rijeka, 51000

Croatia

GC2202 Study Site 802

Zagreb, 10000

Croatia

GC2202 Study Site 305

Székesfehérvár, Fejér 8000

Hungary

GC2202 Study Site 301

Budapest, 1097

Hungary

GC2202 Study Site 308

Budapest, 1122

Hungary

GC2202 Study Site 306

Debrecen, 4032

Hungary

GC2202 Study Site 304

Eger, 3300

Hungary

GC2202 Study Site 302

Győr, 9024

Hungary

GC2202 Study Site 307

Szeged, 6725

Hungary

GC2202 Study Site 303

Szekszárd, 7110

Hungary

GC2202 Study Site 402

Torun, Kuyavian-Pomeranian Voivodeship 87-100

Poland

GC2202 Study Site 401

Krakow, Lesser Poland Voivodeship 30 688

Poland

GC2202 Study Site 401

Krakow, Lesser Poland Voivodeship 31-501

Poland

GC2202 Study Site 403

Legnica, Lower Silesian Voivodeship 59-220

Poland

GC2202 Study Site 406

Wałbrzych, Lower Silesian Voivodeship 58 309

Poland

GC2202 Study Site 406

Wałbrzych, Lower Silesian Voivodeship 58-309

Poland

GC2202 Study Site 405

Słupsk, Pomeranian Voivodeship 76-200

Poland

GC2202 Study Site 408

Bydgoszcz, 85-168

Poland

GC2202 Study Site 410

Krakow, 31-826

Poland

GC2202 Study Site 409

Olsztyn, 10-228

Poland

GC2202 Study Site 407

Torun, 87-100

Poland

GC2202 Study Site 511

Bucharest, Bucharest 022328

Romania

GC2202 Study Site 501

Bucharest, Bucharest 20125

Romania

GC2202 Study Site 503

Brasov, RO 500052

Romania

GC2202 Study Site 504

Bucharest, RO 30171

Romania

GC2202 Study Site 506

Cluj-Napoca, RO 400015

Romania

GC2202 Study Site 502

Timișoara, RO 300041

Romania

GC2202 Study Site 509

Bucharest, 022322

Romania

GC2202 Study Site 508

Bucharest, 050098

Romania

GC2202 Study Site 507

Constanța, 905900

Romania

GC2202 Study Site 510

Iași, 700483

Romania

GC2202 Study Site 602

Belgrade, 11000

Serbia

GC2202 Study Site 604

Belgrade, 11000

Serbia

GC2202 Study Site 605

Belgrade, 11080

Serbia

GC2202 Study Site 607

Belgrade, 11080

Serbia

GC2202 Study Site 603

Kamenitz, 21204

Serbia

GC2202 Study Site 601

Kragujevac, 34000

Serbia

GC2202 Study Site 606

Niš, 18000

Serbia