Panzyga for Chronic Lymphocytic Leukemia

No longer recruiting at 106 trial locations

Overseen By Patrick M Murphy

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Octapharma

Must not be taking: Antibiotics, Immunosuppressants

Disqualifiers: Major infections, Severe liver disease, HIV, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness and safety of Panzyga, an immune globulin therapy, for people with chronic lymphocytic leukemia (CLL), with a focus on preventing infections. Participants will receive either Panzyga or a placebo (a substance with no active drug) to determine which better reduces infection risks. Suitable candidates for this trial include those diagnosed with CLL, currently undergoing treatment, and having low levels of a specific antibody (IgG). As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but you cannot have had IgG treatment within 3 months before the trial or antibiotic treatment within 7 days before the trial, except for certain medications like TMP/SMX, dapsone, and pentamidine inhalation. Also, ongoing immunosuppressive treatment (other than for CLL or corticosteroids) is not allowed during the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Panzyga, a type of intravenous immune globulin (IVIG), is generally safe and well-tolerated. Studies have found it effective and safe for preventing infections in patients with chronic lymphocytic leukemia, helping protect them from illness without causing serious side effects.

Few reports of severe side effects with Panzyga have emerged. While every treatment can have some side effects, evidence suggests that Panzyga's benefits in reducing infections are significant, making it a promising option for patients with weakened immune systems due to leukemia. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for chronic lymphocytic leukemia?

Panzyga is unique because it is an intravenous immunoglobulin (IVIG) treatment that provides a new approach for managing Chronic Lymphocytic Leukemia (CLL). Unlike standard CLL treatments, which often involve chemotherapy or targeted therapies like BTK inhibitors and monoclonal antibodies, Panzyga delivers concentrated antibodies that can bolster the immune system's ability to fight cancer cells. Researchers are excited about Panzyga because it offers a potentially less toxic alternative to traditional chemotherapy, with the added benefit of enhancing immune function, which could improve overall patient outcomes.

What evidence suggests that Panzyga might be an effective treatment for chronic lymphocytic leukemia?

Studies have shown that Panzyga, administered through a drip, can help prevent infections in people with Chronic Lymphocytic Leukemia (CLL). Made from human blood, Panzyga contains antibodies that strengthen the immune system. Research indicates that similar treatments have successfully reduced infection rates in patients with weakened immune systems. Patients with other types of leukemia experienced fewer infections with this kind of treatment. This trial will compare Panzyga to a placebo to evaluate its effectiveness in helping CLL patients at risk of infections. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Hypogammaglobulinemia (IgG levels <5 g/L) as confirmed by the Central Laboratory.

I have CLL and am starting or retrying treatment.

Voluntarily given, fully informed written and signed consent obtained before any study-related procedures are conducted.

Exclusion Criteria

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

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

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Panzyga or placebo for primary infection prophylaxis

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Panzyga
• Placebo

Trial Overview 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.

How Is the Trial Designed?

Group I: Panzyga Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Panzyga is already approved in United States, European Union for the following indications:

Approved in United States as Panzyga for:

• Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
• Primary Immunodeficiency Syndrome
• Immune Thrombocytopenia

Approved in European Union as Panzyga for:

• Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
• Primary Immunodeficiency Syndrome
• Immune Thrombocytopenia

Who Is Running the Clinical Trial?

Octapharma

Lead Sponsor

Trials

86

Recruited

11,300+

Wolfgang Marguerre

Octapharma

Chief Executive Officer since 1983

MBA from INSEAD

Wolfgang Frenzel

Octapharma

Chief Medical Officer since 2010

MD from University of Vienna

Published Research Related to This Trial

Panzyga® is a new 10% intravenous immune globulin that is effective for treating immunodeficiencies and autoimmune diseases, showing high purity and functional IgG activity.

The product is stable for at least two years when refrigerated and can be stored at room temperature for up to twelve months, making it convenient for use in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biochemical characterization and stability of immune globulin intravenous 10% liquid (Panzyga&#174;). Mersich, C., Ahrer, K., Buchacher, A., et al.[2017]

Intravenous and subcutaneous immunoglobulin replacement therapy (IgRT) is effective and safe for preventing infections in patients with chronic lymphocytic leukemia (CLL) and hypogammaglobulinemia, making it an important management tool.

Subcutaneous immunoglobulin (SCIg) formulations are recommended over intravenous immunoglobulin (IVIg) due to their similar efficacy, better cost-effectiveness, and improved tolerability for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Should treatment of hypogammaglobulinemia with immunoglobulin replacement therapy (IgRT) become standard of care in patients with chronic lymphocytic leukemia? Noto, A., Cassin, R., Mattiello, V., et al.[2023]

In a study involving 25 children with primary immunodeficiency, IVIG 10% demonstrated a very low rate of serious bacterial infections at 0.04 per patient-year, indicating its efficacy in preventing infections.

The treatment was found to be safe, with common side effects including abdominal pain, headache, and chills, while maintaining effective immunoglobulin G levels between infusions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravenous immunoglobulin 10% in children with primary immunodeficiency diseases. Ochs, HD., Melamed, I., Borte, M., et al.[2019]

In a phase 3 study involving 51 patients with primary immunodeficiency diseases, panzyga® (intravenous immunoglobulin 10%) effectively prevented serious bacterial infections (SBIs), achieving a low rate of 0.08 SBIs per patient-year.

The treatment was generally well tolerated, with no adverse events leading to withdrawal or death, indicating a favorable safety profile while meeting efficacy standards set by regulatory agencies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Human Intravenous Immunoglobulin 10% (Panzyga®) in Patients with Primary Immunodeficiency Diseases: a Two-Stage, Multicenter, Prospective, Open-Label Study. Borte, M., Melamed, IR., Pulka, G., et al.[2018]

In a study of 15 patients with chronic lymphocytic leukemia (CLL) who had serum IgG levels above 400 mg/dL, 93.3% showed humoral immunodeficiency, indicating that high IgG levels do not guarantee adequate immune function.

Treatment with subcutaneous immunoglobulin (SCIG) significantly increased serum IgG levels and specific immunity to Streptococcus pneumoniae, while also reducing non-neutropenic infections from 14 to 5 during the 24-week treatment period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subcutaneous immunoglobulin replacement for treatment of humoral immune dysfunction in patients with chronic lymphocytic leukemia. Mustafa, SS., Jamshed, S., Vadamalai, K., et al.[2021]

Citations

1. io.nihr.ac.uk io.nihr.ac.uk/wp-content/uploads/2024/04/30381-Immune-globulin-for-Primary-Infection-in-Chronic-Lymphocytic-Leukaemia-V1.0-APR2024-NON-CONF.pdf

Health Technology Briefing April 2024 Human normal immunoglobulin (Panzyga; IVIG) is an intravenous human immune globulin, a 10% liquid preparation that contains immunoglobulin G (IgG).2 IVIG is ...

2. withpower.com withpower.com/trial/phase-3-leukemia-9-2020-6879c

Panzyga for Chronic Lymphocytic Leukemia 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10117948/

An updated perspective on immunoglobulin replacement in ... This review aims to discuss the mechanisms by which CLL-targeted therapy may exert a synergistic therapeutic effect with immunoglobulin replacement therapy.

4. clinicaltrials.eu clinicaltrials.eu/trial/study-on-the-use-of-human-normal-immunoglobulin-for-preventing-infections-in-patients-with-chronic-lymphocytic-leukemia-and-secondary-immunodeficiency/

Study on the Use of Human Normal Immunoglobulin for ... Panzyga is a medication used in this clinical trial to help prevent infections in patients with chronic lymphocytic leukemia (CLL) who have a ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11075150/

Clinical efficacy of prophylactic intravenous immunoglobulin ... IVIG showed promise in reducing COVID-19 infections among elderly patients with DLBCL receiving reduced intensity R-CHOP therapy.

6. biospace.com biospace.com/patient-recruitment-starts-for-the-international-pro-sid-study-evaluating-panzyga-for-primary-prophylaxis-in-patients-with-chronic-lymphocytic-leukaemia-and-secondary-immunodeficiency

Patient recruitment starts for the international PRO-SID ... The study plans to recruit at least 240 adult patients with CLL and hypogammaglobulinaemia (IgG levels < 5 g/L) who are receiving antineoplastic treatment.