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NCT Number: 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

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.

Recruiting

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Xembify

Drug

SC infusion pump

Other names: Immune Globulin Subcutaneous (Human), 20% (IGSC 20%)

Placebo

Drug

SC infusion pump

Other names: 0.9% Normal Saline

Primary outcomes

  1. Annual Rate of Major Bacterial Infections per Year

    Time frame: Up to Week 51

Secondary outcomes

  1. Time to First Onset of Major Bacterial Infection

    Time frame: Up to Week 51

  2. Percentage of Participants who Experience Major Bacterial Infections

    Time frame: Up to Week 51

  3. Rate of all Bacterial Infections Determined by the Investigator

    Time frame: Up to Week 51

  4. Percentage of Participants who Experience Bacterial Infections

    Time frame: Up to Week 51

  5. Time to First Onset of Non-Major Bacterial Infections

    Time frame: Up to Week 51

  6. Number of Days on Which Participants Were on Antibiotics

    Time frame: Up to Week 51

  7. Number of Hospitalizations due to any Infections

    Time frame: Up to Week 51

  8. Duration of Hospitalizations due to any Infections

    Time frame: Up to Week 51

  9. Number of Hospitalizations due to Major Bacterial Infections

    Time frame: Up to Week 51

  10. Duration of Hospitalizations due to Major Bacterial Infections

    Time frame: Up to Week 51

  11. Rate of all Infections as Determined by the Investigator

    Time frame: Up to Week 51

  12. Number of Participants with Validated Infections

    Time frame: Up to Week 51

  13. Time to First Onset of any Infection

    Time frame: Up to Week 51

Study contacts

Contact information is provided by the study sponsor or research team.

Karen Pellath

CONTACT

[email protected]

+1 9194337967

Marina Acosta Enslen

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Grifols Therapeutics LLC

Industry

Registry information

Official study title

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

Acronym: EXCELL

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Dec 9, 2022
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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