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
Sites (61)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Multiprofile Hospital For Active Treatment Burgas AD Coordinator of this site? Confirm its status | Burgas | Bulgaria | Recruiting |
| Medical Centre Pratia Clinic EOOD Coordinator of this site? Confirm its status | Plovdiv | Bulgaria | Recruiting |
| University Multiprofile Hospital For Active Treatment Saint Georgi EAD Coordinator of this site? Confirm its status | Plovdiv | Bulgaria | Recruiting |
| Complex Oncology Center Ruse Ltd. Coordinator of this site? Confirm its status | Ruse | Bulgaria | Recruiting |
| Medicinski Center Syrtuin Ltd. Coordinator of this site? Confirm its status | Sofia | Bulgaria | Recruiting |
| University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD Coordinator of this site? Confirm its status | Sofia | Bulgaria | Recruiting |
| Medical Center Pulmovision Ltd. Coordinator of this site? Confirm its status | Sofia | Bulgaria | Recruiting |
| Specialized Hospital For Active Treatment Of Hematological Diseases EAD Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Recruiting |
| University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Recruiting |
| Multiprofessional Hospital For Active Treatment Health 2012 OOD Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Recruiting |
| UMHAT Sofiamed OOD Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Recruiting |
| Universitetska Parva Mnogoprofilna Bolnitsa Za Aktivno Lechenie Sofia Sv. Yoan Krastitel Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Recruiting |
| Umbal - Prof. D-R Stoyan Kirkovich AD Coordinator of this site? Confirm its status | Stara Zagora | Bulgaria | Recruiting |
| Clinical Hospital Centre Rijeka Coordinator of this site? Confirm its status | Rijeka | Croatia | Recruiting |
| University Hospital Sveti Duh Coordinator of this site? Confirm its status | Zagreb | Croatia | Recruiting |
| Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet Coordinator of this site? Confirm its status | Budapest IX | Hungary | Recruiting |
| Orszagos Onkologiai Intezet Coordinator of this site? Confirm its status | Budapest XII | Hungary | Recruiting |
| University of Debrecen Coordinator of this site? Confirm its status | Debrecen | Hungary | Recruiting |
| Markhot Ferenc Oktatokorhaz es Rendelointezet Coordinator of this site? Confirm its status | Eger | Hungary | Recruiting |
| Petz Aladar Egyetemi Oktato Korhaz Coordinator of this site? Confirm its status | Győr | Hungary | Recruiting |
| University of Szeged Coordinator of this site? Confirm its status | Szeged | Hungary | Recruiting |
| Fejér Megyei Szent György Egyetemi Oktató Kórház Coordinator of this site? Confirm its status | Székesfehérvár | Hungary | Recruiting |
| Tolna Megyei Balassa Janos Korhaz Coordinator of this site? Confirm its status | Szekszárd | Hungary | Recruiting |
| In- Vivo Sp. z o. o. Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Recruiting |
| Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Recruiting |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie Coordinator of this site? Confirm its status | Cracow | Poland | Recruiting |
| Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. z o.o. Coordinator of this site? Confirm its status | Cracow | Poland | Recruiting |
| Wojewodzki Szpital Specjalistyczny w Legnicy Coordinator of this site? Confirm its status | Legnica | Poland | Recruiting |
| Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji z Warmińsko - Mazurskim Centrum Onkologii w Olsztynie Coordinator of this site? Confirm its status | Olsztyn | Poland | Recruiting |
| Wojewodzki Szpital Specjalistyczny Im. Janusza Korczaka W Slupsku Sp. z o.o. Coordinator of this site? Confirm its status | Slupsk | Poland | Recruiting |
| Nasz Lekarz Przychodnie Medyczne Sp. z o.o. Coordinator of this site? Confirm its status | Torun | Poland | Recruiting |
| Specjalistyczny Szpital Miejski Im.Mikolaja Kopernika Coordinator of this site? Confirm its status | Torun | Poland | Recruiting |
| Specjalistyczny Szpital Im. Dra Alfreda Sokolowskiego samodzielny publiczny zakład opieki zdrowotnej Coordinator of this site? Confirm its status | Walbrzych | Poland | Recruiting |
| Onco Card S.R.L. Coordinator of this site? Confirm its status | Brasov | Romania | Recruiting |
| Spitalul Universitar de Urgență București Coordinator of this site? Confirm its status | Bucharest | Romania | Recruiting |
| Spitalul Clinic Colentina Bucuresti Coordinator of this site? Confirm its status | Bucharest | Romania | Recruiting |
| Spitalul Clinic Colțea Coordinator of this site? Confirm its status | Bucharest | Romania | Recruiting |
| Institutul Clinic Fundeni Coordinator of this site? Confirm its status | Bucharest | Romania | Recruiting |
| Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Coordinator of this site? Confirm its status | Cluj-Napoca | Romania | Recruiting |
| Institutul Regional de Oncologie Iasi Coordinator of this site? Confirm its status | Iași | Romania | Recruiting |
| Ovidius Clinical Hospital S.R.L Coordinator of this site? Confirm its status | Ovidiu | Romania | Recruiting |
| Spitalul Clinic Municipal De Urgenta Timisoara Coordinator of this site? Confirm its status | Timisoara | Romania | Recruiting |
| - Coordinator of this site? Confirm its status | Belgrade | Serbia | Recruiting |
| - Coordinator of this site? Confirm its status | Belgrade | Serbia | Recruiting |
| - Coordinator of this site? Confirm its status | Belgrade | Serbia | Withdrawn |
| - Coordinator of this site? Confirm its status | Belgrade | Serbia | Recruiting |
| - Coordinator of this site? Confirm its status | Kamenitz | Serbia | Recruiting |
| - Coordinator of this site? Confirm its status | Kragujevac | Serbia | Recruiting |
| - Coordinator of this site? Confirm its status | Niš | Serbia | Recruiting |
| - Coordinator of this site? Confirm its status | Bethesda | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Bullhead City | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Canton | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Greenville | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Huntington Park | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Morrisville | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Rockville | United States | Withdrawn |
| - Coordinator of this site? Confirm its status | St. Petersburg | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Wilson | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Banja Luka | Bosnia and Herzegovina | Recruiting |
| - Coordinator of this site? Confirm its status | Mostar | Bosnia and Herzegovina | Recruiting |
| - Coordinator of this site? Confirm its status | Sarajevo | Bosnia and Herzegovina | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.