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
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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether XEMBIFY plus standard medical care prevents serious bacterial infections better than a placebo (inactive treatment) plus standard care. Treatment is given every two weeks for one year. It is for adults with certain blood cancers, low levels of infection-fighting antibodies, and repeated or severe infections.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You are age 18 or older.
- You have a confirmed blood cancer: B-cell chronic lymphocytic leukemia (CLL), multiple myeloma, or B-cell non-Hodgkin lymphoma.
- Your cancer meets the study’s stage rules: CLL at Rai stage 1–4, myeloma at R-ISS stage II or III, or lymphoma at stage III or above.
- You have low antibody levels, called hypogammaglobulinemia: your IgG level is below 5 g/L. For myeloma, this level is adjusted to remove abnormal cancer-related protein.
- In the past 12 months, you had at least one severe bacterial or viral infection, rated grade 3 or higher, or at least three infections.
Who can't join
- You had a stem cell transplant from a donor in the past 24 months, or one using your own cells in the past 3 months. You use antibody replacement treatment now or used it in the past 6 months.
- You have an active infection, another active cancer, or a known immune disorder you were born with. A specific disorder called selective IgA deficiency also excludes you. Certain medicines to prevent infections are allowed.
- You are expected to live less than 1.5 years, or have a serious illness that could make the study unsafe or hard to finish.
- You had a serious reaction to antibody treatment or a severe allergic reaction to blood products. You have skin problems or a bleeding disorder that makes treatment under the skin unsafe.
- You have severe kidney disease, certain liver test levels above three times normal, or a known past hepatitis B or C infection or signs of a current infection.
- You have a current blood clot, one clot episode in the past year, or two episodes in your lifetime. You have blood that is too thick or clots too easily, uncontrolled blood pressure above 140/90, or a heart rate above 100 beats per minute.
- You have abused drugs or prescription medicines in the past 12 months.
- You joined another clinical trial in the 30 days before screening. Studies that only observe you and do not test treatments are allowed.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility 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).
Study sites (9)
AZ
- GC2202 Study Site 118 · Bullhead City, AZ 86642 · Study contact · karen.pellath@grifols.comMore trials in Bullhead City
CA
- GC2202 Study Site 115 · Huntington Park, CA 90255 · Study contact · karen.pellath@grifols.comMore trials in Huntington Park
FL
- GC2202 Study Site 103 · St. Petersburg, FL 33701 · Study contact · karen.pellath@grifols.comMore trials in St. Petersburg
MD
- GC2202 Study Site 111 · Bethesda, MD 20889 · Study contact · karen.pellath@grifols.comMore trials in Bethesda
NC
- GC2202 Study Site 109 · Greenville, NC 27843 · Study contact · karen.pellath@grifols.comMore trials in Greenville
- GC2202 Decentralized Study Site 114 · Morrisville, NC 27560 · Study contact · karen.pellath@grifols.comMore trials in Morrisville
- GC2202 Study Site 117 · Wilson, NC 27893 · Study contact · karen.pellath@grifols.comMore trials in Wilson
OH
- GC2202 Study Site 105 · Canton, OH 44718 · Study contact · karen.pellath@grifols.comMore trials in Canton
SC
- GC2202 Study Site 110 · Rockville, SC 29732More trials in Rockville