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Compares treatment options for Hypogammaglobulinemia
Official title 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
ClinicalTrials.gov ID: NCT05645107
What this study is testing
What is Xembify?
Xembify is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for hypogammaglobulinemia.
Also referred to as Immune Globulin Subcutaneous (Human), 20% (IGSC 20%).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- Participants with documented history of hematopoietic stem cell transplant (allogenic transplant in the previous 24 months, and autologous transplant...
- Participants currently receiving immunoglobulin replacement therapy (IgRT) or have received IgG replacement treatment (i.e., prior immune globulin...
- Participants with active infections at time of screening visit. Specific supportive anti-infective prophylactic defined in the CLL National...
- Participants with active second malignancies.
- Participants with known primary immunodeficiency (PI).
- Participants with a life expectancy less than 1.5 years.
See the full eligibility 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 people, 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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)...
- 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-treatment] are permitted).
The study team makes the final eligibility decision.
Where it's taking place
- Huntington Park, California, United States
- St. Petersburg, Florida, United States
- Bethesda, Maryland, United States
- Greenville, North Carolina, United States
- Morrisville, North Carolina, United States
- Canton, Ohio, United States
- Rockville, South Carolina, United States
- Banja Luka, Bosnia and Herzegovina
- Mostar, Bosnia and Herzegovina
- Sarajevo, Bosnia and Herzegovina
- Burgas, Bulgaria
- Plovdiv, Bulgaria
- Rousse, Bulgaria
- Sofia, Bulgaria
- Stara Zagora, Bulgaria
- Rijeka, Croatia
- Zagreb, Croatia
- Székesfehérvár, Fejér, Hungary
- Budapest, Hungary
- Debrecen, Hungary
+ 25 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Huntington Park, California, United States; St. Petersburg, Florida, United States; Bethesda, Maryland, United States; Greenville, North Carolina, United States; Morrisville, North Carolina, United States; Canton, Ohio, United States and 39 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.