Clinical trial NCT04502030: 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)
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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Chronic Lymphocytic Leukemia
Hypogammaglobulinemia
Lead sponsor: Octapharma
Sponsor class: INDUSTRY
First posted: 2020-08-06
Enrollment: 247
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility criteria: 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.

Primary outcomes:
measure: Occurrence of major infections
timeFrame: 52 weeks
Secondary outcomes:
measure: Overall infection rate
timeFrame: 52 weeks
measure: Frequency of prophylaxis with anti-infectives
timeFrame: 52 weeks
measure: Duration of prophylaxis with anti-infectives
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Saint Petersburg
country: United States
facility: Octapharma Research Site
state: Florida
city: Columbus
country: United States
facility: Octapharma Research Site
state: Georgia
city: Macon
country: United States
facility: Octapharma Research Site
state: Georgia
city: New Orleans
country: United States
facility: Octapharma Research Site
state: Louisiana
city: Baltimore
country: United States
facility: Octapharma Research Site
state: Maryland
city: Baltimore
country: United States
facility: Octapharma Research Site
state: Maryland
city: Detroit
country: United States
facility: Octapharma Research Site
state: Michigan
city: Rochester
country: United States
facility: Octapharma Research Site
state: Minnesota
city: Buffalo
country: United States
facility: Octapharma Research Site
state: New York
city: New York
country: United States
facility: Octapharma Research Site
state: New York
city: New York
country: United States
facility: Octapharma Research Site
state: New York
city: Shirley
country: United States
facility: Octapharma Research Site
state: New York
city: Durham
country: United States
facility: Octapharma Research Site
state: North Carolina
city: Charleston
country: United States
facility: Octapharma Research Site
state: South Carolina
city: Houston
country: United States
facility: Octapharma Research Site
state: Texas
city: Brno
country: Czechia
facility: Octapharma Research Site
city: Hradec Králové
country: Czechia
facility: Octapharma Research Site
city: Ostrava
country: Czechia
facility: Octapharma Research Site
city: Aalborg
country: Denmark
facility: Octapharma Research Site
city: Herning
country: Denmark
facility: Octapharma Research Site
city: Roskilde
country: Denmark
facility: Octapharma Research Site
city: Dortmund
country: Germany
facility: Octapharma Research Site
city: Frankfurt
country: Germany
facility: Octapharma Research Site
city: Kiel
country: Germany
facility: Octapharma Research Site
city: Marburg
country: Germany
facility: Octapharma Research Site
city: Athens
country: Greece
facility: Octapharma Research Site
city: Athens
country: Greece
facility: Octapharma Research Site
city: Athens
country: Greece
facility: Octapharma Research Site
city: Ioánnina
country: Greece
facility: Octapharma Research Site
city: Patras
country: Greece
facility: Octapharma Research Site
city: Thessaloníki
country: Greece
facility: Octapharma Research Site
city: Budapest
country: Hungary
facility: Octapharma Research Site
city: Debrecen
country: Hungary
facility: Octapharma Research Site
city: Győr
country: Hungary
facility: Octapharma Research Site
city: Kaposvár
country: Hungary
facility: Octapharma Research Site
city: Nyiregyhaza
country: Hungary
facility: Octapharma Research Site
city: Haifa
country: Israel
facility: Octapharma Research Site
city: Haifa
country: Israel
facility: Octapharma Research Site
city: Petah tikva
country: Israel
facility: Octapharma Research Site
city: Castelfranco Veneto
country: Italy
facility: Octapharma Research Site
city: Milano
country: Italy
facility: Octapharma Research Site
city: Milano
country: Italy
facility: Octapharma Research Site
city: Modena
country: Italy
facility: Octapharma Research Site
city: Orbassano
country: Italy
facility: Octapharma Research Site
city: Padova
country: Italy
facility: Octapharma Research Site
city: Pescara
country: Italy
facility: Octapharma Research Site
city: Reggio Calabria
country: Italy
facility: Octapharma Research Site
city: Rome
country: Italy
facility: Octapharma Research Site
city: Torino
country: Italy
facility: Octapharma Research Site
city: Białystok
country: Poland
facility: Octapharma Research Site
city: Bydgoszcz
country: Poland
facility: Octapharma Research Site
city: Gdańsk
country: Poland
facility: Octapharma Research Site
city: Gdańsk
country: Poland
facility: Octapharma Research Site
city: Gdynia
country: Poland
facility: Octapharma Research Site
city: Katowice
country: Poland
facility: Octapharma Research Site
city: Legnica
country: Poland
facility: Octapharma Research Site
city: Toruń
country: Poland
facility: Octapharma Research Site
city: Warsaw
country: Poland
facility: Octapharma Research Site
city: Wrocław
country: Poland
facility: Octapharma Research Site
city: Łódź
country: Poland
facility: Octapharma Research Site
city: Barnaul
country: Russian Federation
facility: Octapharma Research Site
city: Ekaterinburg
country: Russian Federation
facility: Octapharma Research Site
city: Kemerovo
country: Russian Federation
facility: Octapharma Research Site
city: Moscow
country: Russian Federation
facility: Octapharma Research Site
city: Moscow
country: Russian Federation
facility: Octapharma Research Site
city: Nizhny Novgorod
country: Russian Federation
facility: Octapharma Research Site
city: Novosibirsk
country: Russian Federation
facility: Octapharma Research Site
city: Petrozavodsk
country: Russian Federation
facility: Octapharma Research Site
city: Rostov-on-Don
country: Russian Federation
facility: Octapharma Research Site
city: Saint Petersburg
country: Russian Federation
facility: Octapharma Research Site
city: Samara
country: Russian Federation
facility: Octapharma Research Site
city: Tomsk
country: Russian Federation
facility: Octapharma Research Site
city: Tula
country: Russian Federation
facility: Octapharma Research Site
city: Ufa
country: Russian Federation
facility: Octapharma Research Site
city: Madrid
country: Spain
facility: Octapharma Research Site
city: Madrid
country: Spain
facility: Octapharma Research Site
city: Madrid
country: Spain
facility: Octapharma Research Site
city: Oviedo
country: Spain
facility: Octapharma Research Site
city: Santander
country: Spain
facility: Octapharma Research Site
city: Antalya
country: Turkey
facility: Octapharma Research Site
city: Cebeci/Ankara
country: Turkey
facility: Octapharma Research Site
city: Fatih/Istanbul
country: Turkey
facility: Octapharma Research Site
city: Kazimdirik
country: Turkey
facility: Octapharma Research Site
city: Melikgazi/Kayseri
country: Turkey
facility: Octapharma Research Site
Study officials:
References: