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NCT05645107RecruitingPhase 3

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

Source: ClinicalTrials.gov · Last updated 30 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
386 (estimated)
First submitted
1 Dec 2022
Start date
26 Dec 2022
Primary completion date
Aug 2029
Lead sponsor
Grifols Therapeutics LLC
NCT number
NCT05645107
EU CT number
2022-502193-16-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 386
  • From 26 Dec 2022 to the primary completion date, Aug 2029
  • 61 sites in 8 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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 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 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 have a known previous infection or clinical signs and symptoms consistent with current hepatitis B virus or hepatitis C virus infection.
  • 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).

Other illness

  • 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 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 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 currently have a known hyperviscosity syndrome or hypercoagulable states.
  • 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.

Lab values

  • 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.

Other

  • Participants with known primary immunodeficiency (PI).
  • Participants with a life expectancy less than 1.5 years.
  • Participants have had a known serious adverse reaction (AR) to immunoglobulin or any anaphylactic reaction to blood or any blood-derived product.

Who the study is looking for

  • 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).

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (61)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University Multiprofile Hospital For Active Treatment Burgas AD
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BurgasBulgariaRecruiting
Medical Centre Pratia Clinic EOOD
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PlovdivBulgariaRecruiting
University Multiprofile Hospital For Active Treatment Saint Georgi EAD
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PlovdivBulgariaRecruiting
Complex Oncology Center Ruse Ltd.
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RuseBulgariaRecruiting
Medicinski Center Syrtuin Ltd.
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SofiaBulgariaRecruiting
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD
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SofiaBulgariaRecruiting
Medical Center Pulmovision Ltd.
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SofiaBulgariaRecruiting
Specialized Hospital For Active Treatment Of Hematological Diseases EAD
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SofiyaBulgariaRecruiting
University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov
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SofiyaBulgariaRecruiting
Multiprofessional Hospital For Active Treatment Health 2012 OOD
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SofiyaBulgariaRecruiting
UMHAT Sofiamed OOD
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SofiyaBulgariaRecruiting
Universitetska Parva Mnogoprofilna Bolnitsa Za Aktivno Lechenie Sofia Sv. Yoan Krastitel
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SofiyaBulgariaRecruiting
Umbal - Prof. D-R Stoyan Kirkovich AD
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Stara ZagoraBulgariaRecruiting
Clinical Hospital Centre Rijeka
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RijekaCroatiaRecruiting
University Hospital Sveti Duh
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ZagrebCroatiaRecruiting
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet
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Budapest IXHungaryRecruiting
Orszagos Onkologiai Intezet
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Budapest XIIHungaryRecruiting
University of Debrecen
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DebrecenHungaryRecruiting
Markhot Ferenc Oktatokorhaz es Rendelointezet
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EgerHungaryRecruiting
Petz Aladar Egyetemi Oktato Korhaz
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GyőrHungaryRecruiting
University of Szeged
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SzegedHungaryRecruiting
Fejér Megyei Szent György Egyetemi Oktató Kórház
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SzékesfehérvárHungaryRecruiting
Tolna Megyei Balassa Janos Korhaz
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SzekszárdHungaryRecruiting
In- Vivo Sp. z o. o.
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BydgoszczPolandRecruiting
Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy
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BydgoszczPolandRecruiting
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
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CracowPolandRecruiting
Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. z o.o.
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CracowPolandRecruiting
Wojewodzki Szpital Specjalistyczny w Legnicy
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LegnicaPolandRecruiting
Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji z Warmińsko - Mazurskim Centrum Onkologii w Olsztynie
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OlsztynPolandRecruiting
Wojewodzki Szpital Specjalistyczny Im. Janusza Korczaka W Slupsku Sp. z o.o.
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SlupskPolandRecruiting
Nasz Lekarz Przychodnie Medyczne Sp. z o.o.
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TorunPolandRecruiting
Specjalistyczny Szpital Miejski Im.Mikolaja Kopernika
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TorunPolandRecruiting
Specjalistyczny Szpital Im. Dra Alfreda Sokolowskiego samodzielny publiczny zakład opieki zdrowotnej
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WalbrzychPolandRecruiting
Onco Card S.R.L.
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BrasovRomaniaRecruiting
Spitalul Universitar de Urgență București
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BucharestRomaniaRecruiting
Spitalul Clinic Colentina Bucuresti
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BucharestRomaniaRecruiting
Spitalul Clinic Colțea
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BucharestRomaniaRecruiting
Institutul Clinic Fundeni
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BucharestRomaniaRecruiting
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
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Cluj-NapocaRomaniaRecruiting
Institutul Regional de Oncologie Iasi
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IașiRomaniaRecruiting
Ovidius Clinical Hospital S.R.L
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OvidiuRomaniaRecruiting
Spitalul Clinic Municipal De Urgenta Timisoara
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TimisoaraRomaniaRecruiting
-
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BelgradeSerbiaRecruiting
-
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BelgradeSerbiaRecruiting
-
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BelgradeSerbiaWithdrawn
-
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BelgradeSerbiaRecruiting
-
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KamenitzSerbiaRecruiting
-
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KragujevacSerbiaRecruiting
-
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NišSerbiaRecruiting
-
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BethesdaUnited StatesRecruiting
-
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Bullhead CityUnited StatesRecruiting
-
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CantonUnited StatesRecruiting
-
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GreenvilleUnited StatesRecruiting
-
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Huntington ParkUnited StatesRecruiting
-
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MorrisvilleUnited StatesRecruiting
-
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RockvilleUnited StatesWithdrawn
-
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St. PetersburgUnited StatesRecruiting
-
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WilsonUnited StatesRecruiting
-
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Banja LukaBosnia and HerzegovinaRecruiting
-
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MostarBosnia and HerzegovinaRecruiting
-
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SarajevoBosnia and HerzegovinaNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.