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)

Chronic Lymphocytic Leukemia Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04502030
• Other study ID #: NGAM-12
• Status: Recruiting
• Phase: Phase 3
• Start date: October 5, 2020
• Est. completion date: October 2025

Study information

• Verified date: June 2024
• Source: Octapharma
• Contact: Patrick M Murphy
• Phone: 8663371868
• Email: ctgov[@]clinicalresearchmgt.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: October 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Agammaglobulinemia
• Chronic Lymphocytic Leukemia
• Hypogammaglobulinemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Intervention

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

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
Czechia	Octapharma Research Site	Brno
Czechia	Octapharma Research Site	Hradec Králové
Czechia	Octapharma Research Site	Ostrava
Denmark	Octapharma Research Site	Aalborg
Denmark	Octapharma Research Site	Herning
Denmark	Octapharma Research Site	Roskilde
Germany	Octapharma Research Site	Dortmund
Germany	Octapharma Research Site	Frankfurt
Germany	Octapharma Research Site	Kiel
Germany	Octapharma Research Site	Marburg
Greece	Octapharma Research Site	Athens
Greece	Octapharma Research Site	Athens
Greece	Octapharma Research Site	Athens
Greece	Octapharma Research Site	Ioánnina
Greece	Octapharma Research Site	Patras
Greece	Octapharma Research Site	Thessaloníki
Hungary	Octapharma Research Site	Budapest
Hungary	Octapharma Research Site	Debrecen
Hungary	Octapharma Research Site	Gyor
Hungary	Octapharma Research Site	Kaposvár
Hungary	Octapharma Research Site	Nyiregyhaza
Israel	Octapharma Research Site	Haifa
Israel	Octapharma Research Site	Haifa
Israel	Octapharma Research Site	Petah tikva
Israel	Octapharma Research Site	Tel Aviv
Italy	Octapharma Research Site	Castelfranco Veneto
Italy	Octapharma Research Site	Milano
Italy	Octapharma Research Site	Milano
Italy	Octapharma Research Site	Modena
Italy	Octapharma Research Site	Orbassano
Italy	Octapharma Research Site	Padova
Italy	Octapharma Research Site	Pescara
Italy	Octapharma Research Site	Reggio Calabria
Italy	Octapharma Research Site	Rome
Italy	Octapharma Research Site	Torino
Poland	Octapharma Research Site	Bialystok
Poland	Octapharma Research Site	Bydgoszcz
Poland	Octapharma Research Site	Gdansk
Poland	Octapharma Research Site	Gdansk
Poland	Octapharma Research Site	Gdynia
Poland	Octapharma Research Site	Katowice
Poland	Octapharma Research Site	Legnica
Poland	Octapharma Research Site	Lódz
Poland	Octapharma Research Site	Torun
Poland	Octapharma Research Site	Warsaw
Poland	Octapharma Research Site	Wroclaw
Russian Federation	Octapharma Research Site	Barnaul
Russian Federation	Octapharma Research Site	Ekaterinburg
Russian Federation	Octapharma Research Site	Kemerovo
Russian Federation	Octapharma Research Site	Moscow
Russian Federation	Octapharma Research Site	Moscow
Russian Federation	Octapharma Research Site	Nizhny Novgorod
Russian Federation	Octapharma Research Site	Novosibirsk
Russian Federation	Octapharma Research Site	Petrozavodsk
Russian Federation	Octapharma Research Site	Rostov-on-Don
Russian Federation	Octapharma Research Site	Saint Petersburg
Russian Federation	Octapharma Research Site	Samara
Russian Federation	Octapharma Research Site	Tomsk
Russian Federation	Octapharma Research Site	Tula
Russian Federation	Octapharma Research Site	Ufa
Spain	Octapharma Research Site	Madrid
Spain	Octapharma Research Site	Madrid
Spain	Octapharma Research Site	Madrid
Spain	Octapharma Research Site	Oviedo
Spain	Octapharma Research Site	Santander
Turkey	Octapharma Research Site	Cebeci/Ankara
Turkey	Octapharma Research Site	Fatih/Istanbul
Turkey	Octapharma Research Site	Kazimdirik
Turkey	Octapharma Research Site	Melikgazi/Kayseri
United States	Octapharma Research Site	Baltimore	Maryland
United States	Octapharma Research Site	Baltimore	Maryland
United States	Octapharma Research Site	Buffalo	New York
United States	Octapharma Research Site	Charleston	South Carolina
United States	Octapharma Research Site	Columbus	Georgia
United States	Octapharma Research Site	Detroit	Michigan
United States	Octapharma Research Site	Durham	North Carolina
United States	Octapharma Research Site	Houston	Texas
United States	Octapharma Research Site	Macon	Georgia
United States	Octapharma Research Site	New Orleans	Louisiana
United States	Octapharma Research Site	New York	New York
United States	Octapharma Research Site	New York	New York
United States	Octapharma Research Site	Rochester	Minnesota
United States	Octapharma Research Site	Saint Petersburg	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Octapharma

Countries where clinical trial is conducted

United States,  Czechia,  Denmark,  Germany,  Greece,  Hungary,  Israel,  Italy,  Poland,  Russian Federation,  Spain,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall infection rate	Infection rate for all infections	52 weeks
Secondary	Frequency of prophylaxis with anti-infectives	Inclusive of antibacterials and antivirals	52 weeks
Secondary	Duration of prophylaxis with anti-infectives	Inclusive of antibacterials and antivirals	52 weeks