What side effects are associated with this type of intervention?

Common treatments for Chronic Lymphocytic Leukemia (CLL) include chemoimmunotherapy regimens such as FCR (fludarabine, cyclophosphamide, and rituximab) and BR (bendamustine and rituximab), as well as targeted therapies like ibrutinib and venetoclax. Known side effects of these treatments can vary. FCR is associated with severe neutropenia and infections, while BR has fewer severe toxicities but still includes cytopenias and infections. Ibrutinib can cause diarrhea, peripheral edema, atrial fibrillation, and hypertension. Venetoclax is known for causing tumor lysis syndrome, neutropenia, and gastrointestinal issues. Immunoglobulin Replacement Therapy, like XEMBIFY®, primarily aims to reduce infection rates in patients with hypogammaglobulinemia, and its side effects may include local reactions at the injection site, headache, fatigue, and fever.

What prior FDA approvals exist?

The FDA has approved several treatments for Chronic Lymphocytic Leukemia (CLL), including immunoglobulin replacement therapies like XEMBIFY® for patients with hypogammaglobulinemia to prevent infections. Other related drugs include anti-CD20 monoclonal antibodies such as rituximab, ofatumumab, and obinutuzumab, which target B cells and are used in various combinations with chemotherapy agents like fludarabine and bendamustine. Additionally, Bruton tyrosine kinase (BTK) inhibitors like ibrutinib and acalabrutinib, and BCL-2 inhibitors like venetoclax, have been approved for CLL treatment, offering targeted therapy options.

What other types of research exist?

Promising alternatives to XEMBIFY® for CLL patients include venetoclax plus obinutuzumab, which has shown improved progression-free survival (PFS) and acceptable tolerability. Additionally, Bruton tyrosine kinase (BTK) inhibitors like acalabrutinib and zanubrutinib are effective and better tolerated than ibrutinib. These therapies offer targeted treatment options that may be beneficial for CLL patients.

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Monoclonal Antibodies

XEMBIFY® for Chronic Lymphocytic Leukemia

Q: What is the mechanism of action of this treatment?

Chronic Lymphocytic Leukemia (CLL) treatments include immunoglobulin replacement therapy, chemoimmunotherapy, and targeted agents. Immunoglobulin replacement therapy, such as XEMBIFY®, provides patients with antibodies to help prevent infections, which is crucial for those with hypogammaglobulinemia associated with CLL. Chemoimmunotherapy combines chemotherapy with monoclonal antibodies (e.g., rituximab) to target and kill cancer cells more effectively. Targeted agents, like BTK inhibitors (ibrutinib) and BCL-2 inhibitors (venetoclax), specifically interfere with cancer cell survival pathways, offering a more precise treatment with potentially fewer side effects. These treatments are vital for managing CLL, improving patient outcomes, and reducing complications.

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)

Must not have

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 are currently receiving anti-coagulation therapy which would make SC administration inadvisable (vitamin K antagonists, nonvitamin K antagonist oral anticoagulants [example, dabigatran etexilate targeting Factor IIa, rivaroxaban, edoxaban, and apixaban targeting Factor Xa], and parenteral anticoagulants [example, fondaparinux])

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Pivotal Trial

Summary

This trial is testing if adding XEMBIFY® to usual care can reduce serious bacterial infections in patients with low antibody levels due to a type of leukemia. XEMBIFY® helps by giving extra antibodies to boost the immune system. The goal is to see if this combination works better than usual care alone. XEMBIFY® is used to prevent bacterial infections in patients with chronic lymphocytic 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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My liver enzyme levels are more than three times the normal limit.

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I am on blood thinners that make certain injections unsafe for me.

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I have had a blood clot or stroke in the past year or twice in my lifetime.

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I have had a stem cell transplant.

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My kidney function is severely impaired.

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I have had or currently show signs of hepatitis B or C.

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I have a condition that thickens my blood or makes it clot too easily.

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I have a diagnosed primary immunodeficiency.

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My blood pressure or heart rate is higher than normal.

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I have another active cancer besides the one being treated.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial 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 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.

Group II: Placebo + SMTPlacebo Group1 Intervention

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.

0 / 14Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Chronic Lymphocytic Leukemia (CLL) treatments include immunoglobulin replacement therapy, chemoimmunotherapy, and targeted agents. Immunoglobulin replacement therapy, such as XEMBIFY®, provides patients with antibodies to help prevent infections, which is crucial for those with hypogammaglobulinemia associated with CLL. Chemoimmunotherapy combines chemotherapy with monoclonal antibodies (e.g., rituximab) to target and kill cancer cells more effectively. Targeted agents, like BTK inhibitors (ibrutinib) and BCL-2 inhibitors (venetoclax), specifically interfere with cancer cell survival pathways, offering a more precise treatment with potentially fewer side effects. These treatments are vital for managing CLL, improving patient outcomes, and reducing complications.

Targeted therapy in the treatment of chronic lymphocytic leukemia: facts, shortcomings and hopes for the future.New angles of attack in the fight against chronic lymphocytic leukemia: the advent of novel non-chemotherapeutic agents.Chronic lymphocytic leukemia.