RecruitingPhase 3NCT05645107

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

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


Sponsor

Grifols Therapeutics LLC

Enrollment

386 participants

Start Date

Dec 26, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria7

  • 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).

Exclusion Criteria18

  • Participants with documented history of hematopoietic stem cell transplant.
  • 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

DRUGXembify

SC infusion pump

DRUGPlacebo

SC infusion pump


Locations(61)

GC2202 Study Site 307

Szeged, Hungary

GC2202 Study Site 303

Szekszárd, Hungary

GC2202 Study Site 103

St. Petersburg, Florida, United States

GC2202 Study Site 111

Bethesda, Maryland, United States

GC2202 Study Site 109

Greenville, North Carolina, United States

GC2202 Decentralized Study Site 114

Morrisville, North Carolina, United States

GC2202 Study Site 105

Canton, Ohio, United States

GC2202 Study Site 110

Rockville, South Carolina, United States

GC2202 Study Site 702

Banja Luka, Bosnia and Herzegovina

GC2202 Study Site 703

Mostar, Bosnia and Herzegovina

GC2202 Study Site 701

Sarajevo, Bosnia and Herzegovina

GC2202 Study Site 202

Burgas, Bulgaria

GC2202 Study Site 203

Plovdiv, Bulgaria

GC2202 Study Site 210

Plovdiv, Bulgaria

GC2202 Study Site 205

Rousse, Bulgaria

GC2202 Study Site 209

Sofia, Bulgaria

GC2202 Study Site 201

Sofia, Bulgaria

GC2202 Study Site 206

Sofia, Bulgaria

GC2202 Study Site 207

Sofia, Bulgaria

GC2202 Study Site 211

Sofia, Bulgaria

GC2202 Study Site 212

Sofia, Bulgaria

GC2202 Study Site 213

Sofia, Bulgaria

GC2202 Study Site 204

Sofia, Bulgaria

GC2202 Study Site 208

Sofia, Bulgaria

GC2202 Study Site 214

Stara Zagora, Bulgaria

GC2202 Study Site 801

Rijeka, Croatia

GC2202 Study Site 802

Zagreb, Croatia

GC2202 Study Site 305

Székesfehérvár, Fejér, Hungary

GC2202 Study Site 301

Budapest, Hungary

GC2202 Study Site 308

Budapest, Hungary

GC2202 Study Site 306

Debrecen, Hungary

GC2202 Study Site 304

Eger, Hungary

GC2202 Study Site 302

Győr, Hungary

GC2202 Study Site 402

Torun, Kuyavian-Pomeranian Voivodeship, Poland

GC2202 Study Site 401

Krakow, Lesser Poland Voivodeship, Poland

GC2202 Study Site 401

Krakow, Lesser Poland Voivodeship, Poland

GC2202 Study Site 403

Legnica, Lower Silesian Voivodeship, Poland

GC2202 Study Site 406

Wałbrzych, Lower Silesian Voivodeship, Poland

GC2202 Study Site 406

Wałbrzych, Lower Silesian Voivodeship, Poland

GC2202 Study Site 405

Słupsk, Pomeranian Voivodeship, Poland

GC2202 Study Site 408

Bydgoszcz, Poland

GC2202 Study Site 410

Krakow, Poland

GC2202 Study Site 409

Olsztyn, Poland

GC2202 Study Site 407

Torun, Poland

GC2202 Study Site 503

Brasov, RO, Romania

GC2202 Study Site 504

Bucharest, RO, Romania

GC2202 Study Site 506

Cluj-Napoca, RO, Romania

GC2202 Study Site 502

Timișoara, RO, Romania

GC2202 Study Site 509

Bucharest, Romania

GC2202 Study Site 511

Bucharest, Romania

GC2202 Study Site 508

Bucharest, Romania

GC2202 Study Site 501

Bucharest, Romania

GC2202 Study Site 507

Constanța, Romania

GC2202 Study Site 510

Iași, Romania

GC2202 Study Site 602

Belgrade, Serbia

GC2202 Study Site 604

Belgrade, Serbia

GC2202 Study Site 605

Belgrade, Serbia

GC2202 Study Site 607

Belgrade, Serbia

GC2202 Study Site 603

Kamenitz, Serbia

GC2202 Study Site 601

Kragujevac, Serbia

GC2202 Study Site 606

Niš, Serbia

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NCT05645107


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