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)

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

Study Overview

• Status: Completed
• Conditions: Chronic Lymphocytic Leukemia; Hypogammaglobulinemia
• Intervention / Treatment: Other: Placebo; Biological: Panzyga

• Study Type: Interventional
• Enrollment (Actual): 247
• Phase: Phase 3

Contacts and Locations

Study Locations

• Czechia
  • Brno, Czechia, 625 00
    • Octapharma Research Site
  • Hradec Králové, Czechia, 500 05
    • Octapharma Research Site
  • Ostrava, Czechia, 70852
    • Octapharma Research Site
• Denmark
  • Aalborg, Denmark, 9000
    • Octapharma Research Site
  • Herning, Denmark, 7400
    • Octapharma Research Site
  • Roskilde, Denmark, 4000
    • Octapharma Research Site
• Germany
  • Dortmund, Germany, 44263
    • Octapharma Research Site
  • Frankfurt, Germany, 15236
    • Octapharma Research Site
  • Kiel, Germany, 24105
    • Octapharma Research Site
  • Marburg, Germany, 35037
    • Octapharma Research Site
• Greece
  • Athens, Greece, 10676
    • Octapharma Research Site
  • Athens, Greece, 11526
    • Octapharma Research Site
  • Athens, Greece, 12462
    • Octapharma Research Site
  • Ioannina, Greece, 45500
    • Octapharma Research Site
  • Pátrai, Greece, 26500
    • Octapharma Research Site
  • Thessaloniki, Greece, 57010
    • Octapharma Research Site
• Hungary
  • Budapest, Hungary, 1088
    • Octapharma Research Site
  • Debrecen, Hungary, 4032
    • Octapharma Research Site
  • Győr, Hungary, 9023
    • Octapharma Research Site
  • Kaposvár, Hungary, 7400
    • Octapharma Research Site
  • Nyíregyháza, Hungary, 4400
    • Octapharma Research Site
• Israel
  • Haifa, Israel, 3109601
    • Octapharma Research Site
  • Haifa, Israel, 34362
    • Octapharma Research Site
  • Petah Tikva, Israel, 49100
    • Octapharma Research Site
• Italy
  • Castelfranco Veneto, Italy, 31033
    • Octapharma Research Site
  • Milan, Italy, 20132
    • Octapharma Research Site
  • Milan, Italy, 20162
    • Octapharma Research Site
  • Modena, Italy, 41124
    • Octapharma Research Site
  • Orbassano, Italy, 10043
    • Octapharma Research Site
  • Padua, Italy, 35129
    • Octapharma Research Site
  • Pescara, Italy, 65124
    • Octapharma Research Site
  • Reggio Calabria, Italy, 89133
    • Octapharma Research Site
  • Rome, Italy, 00161
    • Octapharma Research Site
  • Torino, Italy, 10126
    • Octapharma Research Site
• Poland
  • Bialystok, Poland, 15-732
    • Octapharma Research Site
  • Bydgoszcz, Poland, 85-065
    • Octapharma Research Site
  • Gdansk, Poland, 80-214
    • Octapharma Research Site
  • Gdansk, Poland, 80-219
    • Octapharma Research Site
  • Gdynia, Poland, 81-519
    • Octapharma Research Site
  • Katowice, Poland, 40-519
    • Octapharma Research Site
  • Legnica, Poland, 59-220
    • Octapharma Research Site
  • Lodz, Poland, 93-513
    • Octapharma Research Site
  • Torun, Poland, 87-100
    • Octapharma Research Site
  • Warsaw, Poland, 02-776
    • Octapharma Research Site
  • Wroclaw, Poland, 50-367
    • Octapharma Research Site
• Russia
  • Barnaul, Russia, 656024
    • Octapharma Research Site
  • Kemerovo, Russia, 650066
    • Octapharma Research Site
  • Moscow, Russia, 115478
    • Octapharma Research Site
  • Moscow, Russia, 125284
    • Octapharma Research Site
  • Nizhny Novgorod, Russia, 603126
    • Octapharma Research Site
  • Novosibirsk, Russia, 630051
    • Octapharma Research Site
  • Petrozavodsk, Russia, 185019
    • Octapharma Research Site
  • Rostov-on-Don, Russia, 344037
    • Octapharma Research Site
  • Saint Petersburg, Russia, 191024
    • Octapharma Research Site
  • Samara, Russia, 443079
    • Octapharma Research Site
  • Tomsk, Russia, 634063
    • Octapharma Research Site
  • Tula, Russia, 300053
    • Octapharma Research Site
  • Ufa, Russia, 450008
    • Octapharma Research Site
  • Yekaterinburg, Russia, 620102
    • Octapharma Research Site
• Spain
  • Madrid, Spain, 28040
    • Octapharma Research Site
  • Madrid, Spain, 28046
    • Octapharma Research Site
  • Madrid, Spain, 28034
    • Octapharma Research Site
  • Oviedo, Spain, 33011
    • Octapharma Research Site
  • Santander, Spain, 39008
    • Octapharma Research Site
• Turkey (Türkiye)
  • Antalya, Turkey (Türkiye), 7050
    • Octapharma Research Site
  • Cebeci/Ankara, Turkey (Türkiye), 65900
    • Octapharma Research Site
  • Fatih/Istanbul, Turkey (Türkiye), 34093
    • Octapharma Research Site
  • Kazimdirik, Turkey (Türkiye), 35100
    • Octapharma Research Site
  • Melikgazi/Kayseri, Turkey (Türkiye), 38039
    • Octapharma Research Site
• United States
  • Florida
    • St. Petersburg, Florida, United States, 33709
      • Octapharma Research Site
  • Georgia
    • Columbus, Georgia, United States, 31904
      • Octapharma Research Site
    • Macon, Georgia, United States, 31201
      • Octapharma Research Site
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Octapharma Research Site
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Octapharma Research Site
    • Baltimore, Maryland, United States, 21205
      • Octapharma Research Site
  • Michigan
    • Detroit, Michigan, United States, 48093
      • Octapharma Research Site
  • Minnesota
    • Rochester, Minnesota, United States, 55902
      • Octapharma Research Site
  • New York
    • Buffalo, New York, United States, 14260
      • Octapharma Research Site
    • New York, New York, United States, 10065
      • Octapharma Research Site
    • New York, New York, United States, 10032
      • Octapharma Research Site
    • Shirley, New York, United States, 11967
      • Octapharma Research Site
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Octapharma Research Site
  • South Carolina
    • Charleston, South Carolina, United States, 29414
      • Octapharma Research Site
  • Texas
    • Houston, Texas, United States, 77090
      • Octapharma Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; Placebo
Experimental: Panzyga	Biological: Panzyga; Panzyga is a 10% IVIG produced from a pool of human fresh frozen plasma donations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall infection rate	Infection rate for all infections	52 weeks
Frequency of prophylaxis with anti-infectives	Inclusive of antibacterials and antivirals	52 weeks
Duration of prophylaxis with anti-infectives	Inclusive of antibacterials and antivirals	52 weeks

Collaborators and Investigators

• Sponsor: Octapharma

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2020
• Primary Completion (Actual): September 19, 2025
• Study Completion (Actual): September 19, 2025

Study Registration Dates

• First Submitted: August 4, 2020
• First Submitted That Met QC Criteria: August 4, 2020
• First Posted (Actual): August 6, 2020

Study Record Updates

• Last Update Posted (Estimated): October 3, 2025
• Last Update Submitted That Met QC Criteria: October 2, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Chronic Disease; Disease Attributes; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Immunologic Deficiency Syndromes; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Leukemia, B-Cell; Blood Protein Disorders; Leukemia, Lymphoid; Leukemia; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Leukemia, Lymphocytic, Chronic, B-Cell; Agammaglobulinemia; Panzyga
• Other Study ID Numbers: NGAM-12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No