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 (EXCELL)

April 8, 2026 updated by: Grifols Therapeutics LLC

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

386

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: XEMBIFY + Standard Medical Treatment (SMT)

Participants will receive a loading dose of 150 milligrams per kilograms per day (mg/kg/day) (Week 1, Days 1 to 5) subcutaneously (SC) for 5 consecutive daily doses followed by biweekly infusions of 300 mg/kg/2-week starting Week 3 (Day 15) through Week 51 (end of Treatment Phase).

The SMT will include the active treatments and the other supportive treatments that the participants will need during their participation.
Drug: Xembify
SC infusion pump
Other Names:
  • Immune Globulin Subcutaneous (Human), 20% (IGSC 20%)
Placebo Comparator: Placebo + SMT

Participants will receive sterile 0.9 percent Sodium Chloride Injection (commercially available in the corresponding country) starting at Week 1 (Days 1 to 5) SC for 5 consecutive daily doses followed by biweekly infusions starting at Week 3 (Day 15) through Week 51.

The SMT will include the active treatments and the other supportive treatments that the participants will need during their participation.
Drug: Placebo
SC infusion pump
Other Names:
  • 0.9% Normal Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Annual Rate of Major Bacterial Infections per Year
Time Frame: Up to Week 51
Up to Week 51

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to First Onset of Major Bacterial Infection
Time Frame: Up to Week 51
Up to Week 51
Percentage of Participants who Experience Major Bacterial Infections
Time Frame: Up to Week 51
Up to Week 51
Rate of all Bacterial Infections Determined by the Investigator
Time Frame: Up to Week 51
Up to Week 51
Percentage of Participants who Experience Bacterial Infections
Time Frame: Up to Week 51
Up to Week 51
Time to First Onset of Non-Major Bacterial Infections
Time Frame: Up to Week 51
Up to Week 51
Number of Days on Which Participants Were on Antibiotics
Time Frame: Up to Week 51
Up to Week 51
Number of Hospitalizations due to any Infections
Time Frame: Up to Week 51
Up to Week 51
Duration of Hospitalizations due to any Infections
Time Frame: Up to Week 51
Up to Week 51
Number of Hospitalizations due to Major Bacterial Infections
Time Frame: Up to Week 51
Up to Week 51
Duration of Hospitalizations due to Major Bacterial Infections
Time Frame: Up to Week 51
Up to Week 51
Rate of all Infections as Determined by the Investigator
Time Frame: Up to Week 51
Up to Week 51
Number of Participants with Validated Infections
Time Frame: Up to Week 51
Up to Week 51
Time to First Onset of any Infection
Time Frame: Up to Week 51
Up to Week 51

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Grifols Therapeutics LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 26, 2022

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

December 1, 2022

First Submitted That Met QC Criteria

December 1, 2022

First Posted (Actual)

December 9, 2022

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 8, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GC2202
  • 2022-502193-16-00 (Other Identifier: EU CT)
  • XEMBIFY® - CLL, MM, and NHL (Other Identifier: Grifols Therapeutics LLC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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