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
NCT ID: NCT05645107
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
386 participants
INTERVENTIONAL
2022-12-26
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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XEMBIFY + Standard Medical Treatment (SMT)
Participants will receive a loading dose of 150 milligrams per kilograms per day (mg/kg/day) (Week 1, Days 1 to 5) subcutaneously (SC) for 5 consecutive daily doses followed by biweekly infusions of 300 mg/kg/2-week starting Week 3 (Day 15) through Week 51 (end of Treatment Phase).
The SMT will include the active treatments and the other supportive treatments that the participants will need during their participation.
Xembify
SC infusion pump
Placebo + SMT
Participants will receive sterile 0.9 percent Sodium Chloride Injection (commercially available in the corresponding country) starting at Week 1 (Days 1 to 5) SC for 5 consecutive daily doses followed by biweekly infusions starting at Week 3 (Day 15) through Week 51.
The SMT will include the active treatments and the other supportive treatments that the participants will need during their participation.
Placebo
SC infusion pump
Interventions
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Xembify
SC infusion pump
Placebo
SC infusion pump
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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).
18 Years
ALL
No
Sponsors
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Grifols Therapeutics LLC
INDUSTRY
Responsible Party
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Locations
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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 307
Szeged, , Hungary
GC2202 Study Site 303
Szekszárd, , 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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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XEMBIFY® - CLL, MM, and NHL
Identifier Type: OTHER
Identifier Source: secondary_id
2022-502193-16-00
Identifier Type: OTHER
Identifier Source: secondary_id
GC2202
Identifier Type: -
Identifier Source: org_study_id