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Can antibody infusions shield CLL patients from deadly infections?

NCT ID NCT04502030

Disease control Sponsor: Octapharma Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether regular infusions of Panzyga (a concentrated antibody solution from donated blood) could prevent serious infections in people with chronic lymphocytic leukemia (CLL) who also have low antibody levels. The trial included 247 adults with CLL who were receiving cancer treatment. Half got Panzyga, half got a placebo. The goal was to see if Panzyga reduced the number of major infections requiring hospitalization or leading to death.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Panzyga (a human antibody solution given intravenously)
What this could lead to
If it works, this could give CLL patients a way to prevent serious infections while on cancer treatment.
What could go wrong
This is a completed Phase 3 trial, but results are not yet published. The benefit may be modest, and IVIG infusions can cause side effects like headache, fever, or allergic reactions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

247 people

The number who actually took part.

Started

Oct 2020

Finished

Sep 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 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. 2. Hypogammaglobulinemia (IgG levels \<5 g/L) as confirmed by the Central Laboratory. 3. ≥18 years of age. 4. Voluntarily given, fully informed written and signed consent obtained before any study-related procedures are conducted. Exclusion Criteria: 1. IgG treatment within 3 months prior to Screening. 2. Antibiotic prophylaxis and/or treatment within 7 days prior to Baseline (with the exception of trimethoprim-sulfamethoxazole \[TMP/SMX\], diaminodiphenyl sulfone \[dapsone\] and pentamidine inhalation). 3. Current major infection or \>1 major infection in the previous 6 months before Baseline. 4. History of anaphylaxis or severe systemic response to immunoglobulin, blood or plasma-derived products or any Panzyga component. 5. History of a non-CLL malignancy or other medical condition with life-expectancy of less than two years. 6. Severe liver disease, with signs of ascites and/or hepatic encephalopathy. 7. Severe kidney disease (as defined by estimated glomerular filtration rate \[eGFR\] \<30 mL/min/1.73 m2). 8. Body weight \>140 kg. 9. Eastern Cooperative Oncology Group (ECOG) performance score of \>2 (Appendix 1). 10. Female patients of childbearing potential unwilling to use a protocol-required method of contraception (as per protocol section 7.3.9 b) from the Screening Visit throughout the study treatment period and for 30 days following the last dose of study drug. 11. Human immunodeficiency virus (HIV) infection at Screening (defined for the study as positive HIV antibody test). 12. Patients found to be chronic carriers of hepatitis B virus (HBV), defined by positive surface antigen (HBsAg), positive Hepatitis B core antibodies (HBcAb) and/or low HBV titers, who will not receive targeted antiviral therapy while undergoing CLL therapy, and patients with active HBV, defined as high HBV titers. 13. Uncontrolled hepatitis C infection at Screening (defined for the study as positive hepatitis virus C \[HCV\] polymerase chain reaction \[PCR\]). 14. Pregnant and lactating women. 15. Subjects with a history of thromboembolic events (TEE) such as deep vein thrombosis, pulmonary embolism, myocardial infarction, ischemic stroke, transient ischemic attack, peripheral artery disease (Fontaine IV) within 6 months before Baseline. 16. Planned or ongoing immunosuppressive treatment (other than for CLL or corticosteroids) or other forbidden medication during the entire study duration after study enrollment. 17. Participation in another interventional clinical trial that is either blinded or involves an investigational (not approved) product within 3 months before Baseline or during the course of the clinical study. Participation in observational clinical trials or open-label trials involving an approved product may be permitted after consultation with the medical monitor. 18. Known IgA deficiency with antibodies to IgA. 19. Known blood hyperviscosity, or other hypercoagulable states. 20. Patients unable or unwilling to understand or comply with the study protocol.

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Conditions

The condition(s) this trial relates to.

agammaglobulinemia B-cell chronic lymphocytic leukemia syndromic agammaglobulinemia infectious disease prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic lymphocytic leukemia Hypogammaglobulinemia

Contacts and locations

Locations

  • Octapharma Research Site

    St. Petersburg, Florida, 33709, United States

  • Octapharma Research Site

    Columbus, Georgia, 31904, United States

  • Octapharma Research Site

    Macon, Georgia, 31201, United States

  • Octapharma Research Site

    New Orleans, Louisiana, 70112, United States

  • Octapharma Research Site

    Baltimore, Maryland, 21201, United States

  • Octapharma Research Site

    Baltimore, Maryland, 21205, United States

  • Octapharma Research Site

    Detroit, Michigan, 48093, United States

  • Octapharma Research Site

    Rochester, Minnesota, 55902, United States

  • Octapharma Research Site

    Buffalo, New York, 14260, United States

  • Octapharma Research Site

    New York, New York, 10032, United States

  • Octapharma Research Site

    New York, New York, 10065, United States

  • Octapharma Research Site

    Shirley, New York, 11967, United States

  • Octapharma Research Site

    Durham, North Carolina, 27710, United States

  • Octapharma Research Site

    Charleston, South Carolina, 29414, United States

  • Octapharma Research Site

    Houston, Texas, 77090, United States

  • Octapharma Research Site

    Brno, 625 00, Czechia

  • Octapharma Research Site

    Hradec Králové, 500 05, Czechia

  • Octapharma Research Site

    Ostrava, 70852, Czechia

  • Octapharma Research Site

    Aalborg, 9000, Denmark

  • Octapharma Research Site

    Herning, 7400, Denmark

  • Octapharma Research Site

    Roskilde, 4000, Denmark

  • Octapharma Research Site

    Dortmund, 44263, Germany

  • Octapharma Research Site

    Frankfurt, 15236, Germany

  • Octapharma Research Site

    Kiel, 24105, Germany

  • Octapharma Research Site

    Marburg, 35037, Germany

  • Octapharma Research Site

    Athens, 10676, Greece

  • Octapharma Research Site

    Athens, 11526, Greece

  • Octapharma Research Site

    Athens, 12462, Greece

  • Octapharma Research Site

    Ioannina, 45500, Greece

  • Octapharma Research Site

    Pátrai, 26500, Greece

  • Octapharma Research Site

    Thessaloniki, 57010, Greece

  • Octapharma Research Site

    Budapest, 1088, Hungary

  • Octapharma Research Site

    Debrecen, 4032, Hungary

  • Octapharma Research Site

    Győr, 9023, Hungary

  • Octapharma Research Site

    Kaposvár, 7400, Hungary

  • Octapharma Research Site

    Nyíregyháza, 4400, Hungary

  • Octapharma Research Site

    Haifa, 3109601, Israel

  • Octapharma Research Site

    Haifa, 34362, Israel

  • Octapharma Research Site

    Petah Tikva, 49100, Israel

  • Octapharma Research Site

    Castelfranco Veneto, 31033, Italy

  • Octapharma Research Site

    Milan, 20132, Italy

  • Octapharma Research Site

    Milan, 20162, Italy

  • Octapharma Research Site

    Modena, 41124, Italy

  • Octapharma Research Site

    Orbassano, 10043, Italy

  • Octapharma Research Site

    Padova, 35129, Italy

  • Octapharma Research Site

    Pescara, 65124, Italy

  • Octapharma Research Site

    Reggio Calabria, 89133, Italy

  • Octapharma Research Site

    Rome, 00161, Italy

  • Octapharma Research Site

    Torino, 10126, Italy

  • Octapharma Research Site

    Bialystok, 15-732, Poland

  • Octapharma Research Site

    Bydgoszcz, 85-065, Poland

  • Octapharma Research Site

    Gdansk, 80-214, Poland

  • Octapharma Research Site

    Gdansk, 80-219, Poland

  • Octapharma Research Site

    Gdynia, 81-519, Poland

  • Octapharma Research Site

    Katowice, 40-519, Poland

  • Octapharma Research Site

    Legnica, 59-220, Poland

  • Octapharma Research Site

    Lodz, 93-513, Poland

  • Octapharma Research Site

    Torun, 87-100, Poland

  • Octapharma Research Site

    Warsaw, 02-776, Poland

  • Octapharma Research Site

    Wroclaw, 50-367, Poland

  • Octapharma Research Site

    Barnaul, 656024, Russia

  • Octapharma Research Site

    Kemerovo, 650066, Russia

  • Octapharma Research Site

    Moscow, 115478, Russia

  • Octapharma Research Site

    Moscow, 125284, Russia

  • Octapharma Research Site

    Nizhny Novgorod, 603126, Russia

  • Octapharma Research Site

    Novosibirsk, 630051, Russia

  • Octapharma Research Site

    Petrozavodsk, 185019, Russia

  • Octapharma Research Site

    Rostov-on-Don, 344037, Russia

  • Octapharma Research Site

    Saint Petersburg, 191024, Russia

  • Octapharma Research Site

    Samara, 443079, Russia

  • Octapharma Research Site

    Tomsk, 634063, Russia

  • Octapharma Research Site

    Tula, 300053, Russia

  • Octapharma Research Site

    Ufa, 450008, Russia

  • Octapharma Research Site

    Yekaterinburg, 620102, Russia

  • Octapharma Research Site

    Madrid, 28034, Spain

  • Octapharma Research Site

    Madrid, 28040, Spain

  • Octapharma Research Site

    Madrid, 28046, Spain

  • Octapharma Research Site

    Oviedo, 33011, Spain

  • Octapharma Research Site

    Santander, 39008, Spain

  • Octapharma Research Site

    Ankara, 65900, Turkey (Türkiye)

  • Octapharma Research Site

    Antalya, 7050, Turkey (Türkiye)

  • Octapharma Research Site

    Istanbul, 34093, Turkey (Türkiye)

  • Octapharma Research Site

    Izmir, 35100, Turkey (Türkiye)

  • Octapharma Research Site

    Kayseri, 38039, Turkey (Türkiye)

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