What side effects are associated with this type of intervention?

Common treatments for Chronic Lymphocytic Leukemia (CLL) include intravenous immunoglobulin (IVIG), anti-CD20 monoclonal antibodies (such as rituximab), and targeted therapies like ibrutinib. IVIG is generally well tolerated, with minor side effects such as febrile reactions, shivering, and headache occurring in about 25% of patients. Rituximab can cause infusion reactions, which are more common and severe in the first cycle, especially in patients with high white blood cell counts. Other side effects of rituximab include infections like pneumonia and cellulitis. Ibrutinib is associated with hematologic adverse effects, atrial fibrillation, hypertension, and infections, particularly during the first six cycles of treatment.

What prior FDA approvals exist?

The FDA has approved several treatments for Chronic Lymphocytic Leukemia (CLL) that involve boosting the immune system. Obinutuzumab, an anti-CD20 monoclonal antibody, was approved in combination with chlorambucil for frontline treatment of CLL. This drug works by targeting B cells and enhancing the immune response. Rituximab, another anti-CD20 monoclonal antibody, has also been widely used in combination therapies such as FCR (fludarabine, cyclophosphamide, rituximab) and BR (bendamustine, rituximab). These treatments aim to improve immune function and target cancer cells. While Panzyga (Intravenous Immunoglobulin) specifically provides antibodies to boost the immune system, the mentioned monoclonal antibodies also play a crucial role in enhancing immune responses in CLL patients.

What other types of research exist?

Promising novel alternatives to Panzyga for CLL patients include: 1) BTK inhibitors such as ibrutinib, acalabrutinib, and zanubrutinib, which are used as single agents or in combination with obinutuzumab. 2) Venetoclax combined with obinutuzumab, which offers a fixed-duration treatment option. These therapies have demonstrated superior efficacy and tolerability in clinical trials compared to traditional chemoimmunotherapy.

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Immunoglobulin Replacement Therapy

Panzyga for Chronic Lymphocytic Leukemia

Phase 3

Waitlist Available

Research Sponsored by Octapharma

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

≥18 years of age.

Treatment-naïve or relapsed/refractory CLL patients undergoing CLL antineoplastic treatment. Diagnosis of B-cell CLL established according to International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria and documented within medical records.

Must not have

Severe liver disease, with signs of ascites and/or hepatic encephalopathy.

Planned or ongoing immunosuppressive treatment (other than for CLL or corticosteroids) or other forbidden medication during the entire study duration after study enrollment.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 52 weeks

Awards & highlights

Pivotal Trial

Summary

This trial is testing Panzyga, a medication made from human blood plasma, to see if it can help prevent infections in patients with Chronic Lymphocytic Leukemia. These patients have weakened immune systems and need extra antibodies to fight off infections. Panzyga is used to prevent serious bacterial infections.

Who is the study for?

This trial is for adults over 18 with Chronic Lymphocytic Leukemia (CLL) who have low IgG levels and are either untreated or relapsed. They must not have had major infections recently, severe liver or kidney disease, weigh over 140 kg, or be HIV positive. Women of childbearing age must agree to use contraception.

What is being tested?

The study tests Panzyga's effectiveness in preventing infections in CLL patients compared to a placebo. It's double-blind meaning neither the participants nor the researchers know who gets what treatment until after the results are analyzed.

What are the potential side effects?

Possible side effects include allergic reactions like anaphylaxis, systemic responses to immunoglobulin or blood products, and potential increased risk of blood clots due to hypercoagulable states.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have CLL and am starting or retrying treatment.

Exclusion Criteria

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

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I have severe liver disease with symptoms like fluid in the abdomen or confusion.

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I am not on any immunosuppressive drugs or forbidden medications for the study.

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I have a condition or cancer other than CLL that may shorten my life to under two years.

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I have tested positive for HIV.

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My daily activity is significantly limited due to my health.

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I do not have an active hepatitis C infection.

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I have had a clotting event like a stroke or deep vein thrombosis in the past 6 months.

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I have not received IgG treatment in the last 3 months.

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I have chronic hepatitis B but won't get antiviral therapy during my CLL treatment.

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My kidney function is severely impaired.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 52 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~52 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Occurrence of major infections

Secondary study objectives

Duration of prophylaxis with anti-infectives

Frequency of prophylaxis with anti-infectives

Overall infection rate

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: PanzygaExperimental Treatment1 Intervention

Group II: PlaceboPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Panzyga

2011

N/A

~350

0 / 12Eligibility 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

The most common treatments for Chronic Lymphocytic Leukemia (CLL) include Bruton tyrosine kinase (BTK) inhibitors (e.g., ibrutinib), which block signals that promote the survival and proliferation of CLL cells; BCL2 inhibitors (e.g., venetoclax), which induce apoptosis in CLL cells by inhibiting the BCL2 protein; and monoclonal antibodies (e.g., rituximab), which target specific antigens on CLL cells to mark them for destruction by the immune system. Intravenous immunoglobulin (IVIG), such as Panzyga, provides a broad spectrum of antibodies that can enhance the immune response and reduce the risk of infections, which is particularly important for CLL patients who are often immunocompromised. These treatments are crucial as they not only target the cancer cells but also help manage the immune deficiencies associated with CLL, improving patient outcomes and quality of life.