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Evaluating XEMBIFY® with standard treatment to prevent infections in patients with certain blood cancers

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

PHASE3 · Grifols Therapeutics LLC · NCT05645107

This study is testing if adding XEMBIFY® to standard treatment can help prevent serious infections in adults with certain blood cancers.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment386 (estimated)
Ages18 Years and up
SexAll
SponsorGrifols Therapeutics LLC (industry)
Locations62 sites (Huntington Park, California and 61 other locations)
Trial IDNCT05645107 on ClinicalTrials.gov

What this trial studies

This study aims to assess the efficacy and safety of XEMBIFY® combined with Standard Medical Treatment (SMT) in reducing major bacterial infections in adults with hypogammaglobulinemia (HGG) associated with B-cell Chronic Lymphocytic Leukemia (CLL), Multiple Myeloma (MM), and Non-Hodgkin Lymphoma (NHL). Participants will receive biweekly doses of XEMBIFY® or a placebo over a one-year period. The primary outcome will measure the rate of major bacterial infections per participant per year, comparing the treatment group to the placebo group. This Phase 3 interventional trial is designed to provide insights into the potential benefits of XEMBIFY® in this patient population.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with a confirmed diagnosis of B-cell CLL, MM, or NHL, who also have low IgG levels and a history of severe or recurrent infections.

Not a fit: Patients without a documented history of severe bacterial infections or those with IgG levels above 5 g/L may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the incidence of severe bacterial infections in patients with specific blood cancers and hypogammaglobulinemia.

How similar studies have performed: Previous studies have shown promising results with similar treatments in reducing infection rates in patients with hypogammaglobulinemia, suggesting potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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 Criteria:

* 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).

Where this trial is running

Huntington Park, California and 61 other locations

+12 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Hypogammaglobulinemia, Bacterial Infections, B-cell Chronic Lymphocytic Leukemia, Multiple Myleoma, Non-Hodgkin Lymphoma, XEMBIFY, CLL, SMT

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.