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Monoclonal Antibodies
XEMBIFY® for Chronic Lymphocytic Leukemia
Phase 3
Recruiting
Research Sponsored by Grifols Therapeutics LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants with RAI staging of intermediate (1 and 2) or high (3 and 4) as documented in the participant's medical history
Participants with hypogammaglobulinemia with immunoglobulin G (IgG) levels <4 grams per liter (g/L)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 53
Awards & highlights
Study Summary
This trial is to see if a new drug can help reduce bacterial infections in people with a type of leukemia.
Who is the study for?
Adults over 18 with B-cell chronic lymphocytic leukemia and low immunoglobulin G levels who've had severe or repeated bacterial infections. Not for those with short life expectancy, certain diseases, on anticoagulants, high blood pressure, recent other trials, kidney disease, current infection treatments (except specific prophylactics), prior immunoglobulin therapy within 6 months, liver issues, skin disorders contraindicating subcutaneous therapy, drug abuse history within a year, active second cancers or known primary immunodeficiency.Check my eligibility
What is being tested?
The trial tests if XEMBIFY® plus Standard Medical Treatment reduces major bacterial infections in patients with hypogammaglobulinemia from B-cell CLL compared to a placebo group. It's administered weekly for one year to see the difference in infection rates between the two groups.See study design
What are the potential side effects?
Possible side effects of XEMBIFY® may include reactions at the injection site such as pain or discomfort; allergic reactions; headache; nausea; fatigue; and potentially more serious complications like thromboembolic events although not all participants will experience these.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is classified as intermediate or high risk.
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My IgG levels are below 4 g/L.
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My diagnosis is B-cell CLL, confirmed by international standards.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to week 53
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 53
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Annual Rate of Major Bacterial Infections per Year
Secondary outcome measures
Duration of Hospitalizations due to Major Bacterial Infections
Duration of Hospitalizations due to any Infections
Number of Days on Which Participants Were on Antibiotics
+10 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: XEMBIFY + Standard Medical Treatment (SMT)Experimental Treatment1 Intervention
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 weekly infusions of 150 mg/kg starting Week 2 (Day 8) through Week 53 (end of Treatment Phase).
The SMT will include the antileukemic treatments and the other supportive treatments that the participants will need during their participation.
Group II: Placebo + SMTPlacebo Group1 Intervention
Participants will receive sterile 0.9 percent Sodium Chloride Injection, United States Pharmacopeia (USP) or equivalent starting at Week 1 (Days 1 to 5) SC for 5 consecutive daily doses followed by weekly infusions starting at Week 2 (Day 8) through Week 53.
The SMT will include the antileukemic treatments and the other supportive treatments that the participants will need during their participation.
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Who is running the clinical trial?
Grifols Therapeutics LLCLead Sponsor
57 Previous Clinical Trials
5,422 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My liver enzyme levels are more than three times the normal limit.My cancer is classified as intermediate or high risk.I have been diagnosed with Selective IgA Deficiency.I do not have any major health issues that could affect my participation in the trial.You have a history of skin conditions that can cause blisters or bleeding, or frequent skin infections.I am on blood thinners that make certain injections unsafe for me.My IgG levels are below 4 g/L.I am not currently being treated for an active infection, except for preventive reasons as outlined in CLL guidelines.I have had a blood clot or stroke in the past year or twice in my lifetime.I have had a stem cell transplant.My kidney function is severely impaired.You have experienced a severe allergic reaction to immunoglobulin or any blood-related product in the past.I have had or currently show signs of hepatitis B or C.My diagnosis is B-cell CLL, confirmed by international standards.I have a condition that thickens my blood or makes it clot too easily.I have had a severe bacterial infection or multiple infections in the past year.You have a predicted lifespan of less than 1.5 years.I am currently on immunoglobulin replacement therapy or had it within the last 6 months.I have a diagnosed primary immunodeficiency.I am 18 years old or older.My blood pressure or heart rate is higher than normal.You have used illegal drugs or abused prescription medications within the past year.I have another active cancer besides the one being treated.
Research Study Groups:
This trial has the following groups:- Group 1: XEMBIFY + Standard Medical Treatment (SMT)
- Group 2: Placebo + SMT
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is it secure to combine XEMBIFY with Standard Medical Treatment (SMT) for patient use?
"XEMBIFY + Standard Medical Treatment (SMT) received a rating of 3 on our safety scale due the fact that this is a Phase 3 trial, indicating prior evidence demonstrating both efficacy and security."
Answered by AI
Is recruitment for this experiment ongoing?
"As indicated on clinicaltrials.gov, this trial is presently not taking any more participants. Initially published on December 17th 2022 and most recently updated a fortnight prior, the study has concluded its recruitment period; however there are 2322 other research projects currently seeking volunteers at present."
Answered by AI
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