Double-blind, Randomized, Placebo-controlled, Prospective Phase III Study Evaluating Efficacy and Safety of Panzyga in Primary Infection Prophylaxis in Patients With Chronic Lymphocytic Leukemia ("PRO-SID" Study)

NCT04502030 | Completed Phase 3 FDA Drug

• 1 other identifier: NGAM-12
• Study Type: interventional
• Target: 247
• Locations: 12 countries
• Sites: 84

Brief Summary

Study Evaluating Efficacy and Safety of Panzyga in Primary Infection Prophylaxis in Patients with Chronic Lymphocytic Leukemia

Conditions

Chronic Lymphocytic Leukemia; Hypogammaglobulinemia

Outcome Measures

Primary Outcomes (1)

• Occurrence of major infections

  Major infection for this trial is defined as: * Bacterial and/or viral infections resulting in death * Bacterial and/or viral infections, which are microbiologically documented (MDI) or clinically documented (CDI) requiring treatment with anti-infectives; upper respiratory tract infections, bronchitis, lower urinary tract infections, localized skin infections and stomatitis (MDI or CDI) are considered major only if they require treatment with antiinfectives AND hospitalization or hospitalization prolongation. * Fever of unknown origin (FUO) requiring hospitalization or hospitalization prolongation

  52 weeks

Secondary Outcomes (3)

• Overall infection rate

  52 weeks

• Frequency of prophylaxis with anti-infectives

  52 weeks

• Duration of prophylaxis with anti-infectives

  52 weeks

Study Arms (2)

Panzyga

EXPERIMENTAL

Biological: Panzyga

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Panzyga BIOLOGICAL

Panzyga is a 10% IVIG produced from a pool of human fresh frozen plasma donations

Panzyga

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Hypogammaglobulinemia (IgG levels \<5 g/L) as confirmed by the Central Laboratory.
• ≥18 years of age.
• Voluntarily given, fully informed written and signed consent obtained before any study-related procedures are conducted.

You may not qualify if:

• IgG treatment within 3 months prior to Screening.
• 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).
• Current major infection or \>1 major infection in the previous 6 months before Baseline.
• History of anaphylaxis or severe systemic response to immunoglobulin, blood or plasma-derived products or any Panzyga component.
• History of a non-CLL malignancy or other medical condition with life-expectancy of less than two years.
• Severe liver disease, with signs of ascites and/or hepatic encephalopathy.
• Severe kidney disease (as defined by estimated glomerular filtration rate \[eGFR\] \<30 mL/min/1.73 m2).
• Body weight \>140 kg.
• Eastern Cooperative Oncology Group (ECOG) performance score of \>2 (Appendix 1).
• 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.
• Human immunodeficiency virus (HIV) infection at Screening (defined for the study as positive HIV antibody test).
• 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.
• Uncontrolled hepatitis C infection at Screening (defined for the study as positive hepatitis virus C \[HCV\] polymerase chain reaction \[PCR\]).
• Pregnant and lactating women.
• 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.

Sponsors & Collaborators

• Octapharma: lead

Study Sites (84)

Octapharma Research Site

St. Petersburg, Florida, 33709, United States

Location

Octapharma Research Site

Columbus, Georgia, 31904, United States

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Octapharma Research Site

Macon, Georgia, 31201, United States

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Octapharma Research Site

New Orleans, Louisiana, 70112, United States

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Octapharma Research Site

Baltimore, Maryland, 21201, United States

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Octapharma Research Site

Baltimore, Maryland, 21205, United States

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Octapharma Research Site

Detroit, Michigan, 48093, United States

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Octapharma Research Site

Rochester, Minnesota, 55902, United States

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Octapharma Research Site

Buffalo, New York, 14260, United States

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Octapharma Research Site

New York, New York, 10032, United States

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Octapharma Research Site

New York, New York, 10065, United States

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Octapharma Research Site

Shirley, New York, 11967, United States

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Octapharma Research Site

Durham, North Carolina, 27710, United States

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Octapharma Research Site

Charleston, South Carolina, 29414, United States

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Octapharma Research Site

Houston, Texas, 77090, United States

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Octapharma Research Site

Brno, 625 00, Czechia

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Octapharma Research Site

Hradec Králové, 500 05, Czechia

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Octapharma Research Site

Ostrava, 70852, Czechia

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Octapharma Research Site

Aalborg, 9000, Denmark

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Octapharma Research Site

Herning, 7400, Denmark

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Octapharma Research Site

Roskilde, 4000, Denmark

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Octapharma Research Site

Dortmund, 44263, Germany

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Octapharma Research Site

Frankfurt, 15236, Germany

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Octapharma Research Site

Kiel, 24105, Germany

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Octapharma Research Site

Marburg, 35037, Germany

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Octapharma Research Site

Athens, 10676, Greece

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Octapharma Research Site

Athens, 11526, Greece

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Octapharma Research Site

Athens, 12462, Greece

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Octapharma Research Site

Ioannina, 45500, Greece

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Octapharma Research Site

Pátrai, 26500, Greece

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Octapharma Research Site

Thessaloniki, 57010, Greece

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Octapharma Research Site

Budapest, 1088, Hungary

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Octapharma Research Site

Debrecen, 4032, Hungary

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Octapharma Research Site

Győr, 9023, Hungary

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Octapharma Research Site

Kaposvár, 7400, Hungary

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Octapharma Research Site

Nyíregyháza, 4400, Hungary

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Octapharma Research Site

Haifa, 3109601, Israel

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Octapharma Research Site

Haifa, 34362, Israel

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Octapharma Research Site

Petah Tikva, 49100, Israel

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Octapharma Research Site

Castelfranco Veneto, 31033, Italy

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Octapharma Research Site

Milan, 20132, Italy

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Octapharma Research Site

Milan, 20162, Italy

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Octapharma Research Site

Modena, 41124, Italy

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Octapharma Research Site

Orbassano, 10043, Italy

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Octapharma Research Site

Padua, 35129, Italy

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Octapharma Research Site

Pescara, 65124, Italy

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Octapharma Research Site

Reggio Calabria, 89133, Italy

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Octapharma Research Site

Rome, 00161, Italy

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Octapharma Research Site

Torino, 10126, Italy

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Octapharma Research Site

Bialystok, 15-732, Poland

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Octapharma Research Site

Bydgoszcz, 85-065, Poland

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Octapharma Research Site

Gdansk, 80-214, Poland

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Octapharma Research Site

Gdansk, 80-219, Poland

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Octapharma Research Site

Gdynia, 81-519, Poland

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Octapharma Research Site

Katowice, 40-519, Poland

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Octapharma Research Site

Legnica, 59-220, Poland

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Octapharma Research Site

Lodz, 93-513, Poland

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Octapharma Research Site

Torun, 87-100, Poland

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Octapharma Research Site

Warsaw, 02-776, Poland

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Octapharma Research Site

Wroclaw, 50-367, Poland

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Octapharma Research Site

Barnaul, 656024, Russia

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Octapharma Research Site

Kemerovo, 650066, Russia

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Octapharma Research Site

Moscow, 115478, Russia

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Octapharma Research Site

Moscow, 125284, Russia

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Octapharma Research Site

Nizhny Novgorod, 603126, Russia

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Octapharma Research Site

Novosibirsk, 630051, Russia

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Octapharma Research Site

Petrozavodsk, 185019, Russia

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Octapharma Research Site

Rostov-on-Don, 344037, Russia

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Octapharma Research Site

Saint Petersburg, 191024, Russia

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Octapharma Research Site

Samara, 443079, Russia

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Octapharma Research Site

Tomsk, 634063, Russia

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Octapharma Research Site

Tula, 300053, Russia

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Octapharma Research Site

Ufa, 450008, Russia

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Octapharma Research Site

Yekaterinburg, 620102, Russia

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Octapharma Research Site

Madrid, 28034, Spain

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Octapharma Research Site

Madrid, 28040, Spain

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Octapharma Research Site

Madrid, 28046, Spain

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Octapharma Research Site

Oviedo, 33011, Spain

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Octapharma Research Site

Santander, 39008, Spain

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Octapharma Research Site

Antalya, 7050, Turkey (Türkiye)

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Octapharma Research Site

Cebeci/Ankara, 65900, Turkey (Türkiye)

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Octapharma Research Site

Fatih/Istanbul, 34093, Turkey (Türkiye)

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Octapharma Research Site

Kazimdirik, 35100, Turkey (Türkiye)

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Octapharma Research Site

Melikgazi/Kayseri, 38039, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell; Agammaglobulinemia

Interventions

Panzyga

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Blood Protein Disorders; Immunologic Deficiency Syndromes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2020
• First Posted: August 6, 2020
• Study Start: October 5, 2020
• Primary Completion: September 19, 2025
• Study Completion: September 19, 2025
• Last Updated: October 3, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (5); US (15); CZ (3); GR (6); TU (5); DK (3); IL (3); RU (14); IT (10); DE (4); HU (5); PL (11)