XEMBIFY® for Preventing Infections in Blood Cancers
This study is testing if XEMBIFY® (a drug given by a small pump under the skin) plus standard medical treatment can help prevent serious bacterial infections in people with certain blood cancers like B-cell Chronic Lymphocytic Leukemia (CLL), Multiple Myeloma (MM), and Non-Hodgkin Lymphoma (NHL). These individuals also have hypogammaglobulinemia (HGG), which means they have low levels of antibodies and are more prone to infections. You could be eligible if you are 18 or older and have a confirmed diagnosis of one of these conditions. The main goal is to see if XEMBIFY® reduces the number of major bacterial infections over one year compared to a placebo (an inactive substance) plus standard medical treatment. The current status of this study is unclear.
- Study design
- This is an interventional study comparing XEMBIFY® to a placebo, both given with standard medical treatment. It plans to enroll 386 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 51 weeks to measure the rate of major bacterial infections.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05645107
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
Recruiting
PHASE3Ages 18+InterventionalTreatmentGrifols Therapeutics LLC
~386 participants
Updated 2026-07-29 on ClinicalTrials.gov
What's tested:XembifyPlacebo
At a glance
Recruiting sites
56 of 62 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Annual Rate of Major Bacterial Infections per Year
Measured over Up to Week 51
Conditions
Where it's being run
62 sites across 20 statesBulgaria14
Hungary7
Serbia7
Poland4
RO4
Romania4
Bosnia and Herzegovina3
Lower Silesian Voivodeship3
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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).
What this trial measures
- Annual Rate of Major Bacterial Infections per YearUp to Week 51