Chronic Lymphocytic Leukemia Clinical Trial
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
Treatment-naïve or relapsed/refractory leukemia-cll/" >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.
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.
Planned or ongoing immunosuppressive treatment (other than for CLL or corticosteroids) or other forbidden medication during the entire study duration after study enrollment.
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.
Known IgA deficiency with antibodies to IgA.
Known blood hyperviscosity, or other hypercoagulable states.
Patients unable or unwilling to understand or comply with the study protocol.
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There are 43 Locations for this study
Saint Petersburg Florida, 33709, United States
Columbus Georgia, 31904, United States
Columbus Georgia, 31909, United States
Baltimore Maryland, 21224, United States
Detroit Michigan, 48093, United States
Rochester Minnesota, 55902, United States
New York New York, 10032, United States
New York New York, 10065, United States
Durham North Carolina, 27710, United States
Houston Texas, 77090, United States
Aalborg , 9000, Denmark
Holstebro , 7500, Denmark
Roskilde , 4000, Denmark
Dortmund , 44263, Germany
Frankfurt , 15236, Germany
Frechen , 50226, Germany
Goslar , 38642, Germany
Kiel , 24105, Germany
Marburg , 35037, Germany
Budapest , 1083, Hungary
Debrecen , 4032, Hungary
Győr , H-902, Hungary
Kaposvár , 7400, Hungary
Nyiregyhaza , 4400, Hungary
Haifa , , Israel
Petah tikva , , Israel
Tel Aviv , , Israel
Milano , 20132, Italy
Milano , 20162, Italy
Orbassano , , Italy
Padova , 35128, Italy
Reggio Calabria , , Italy
Rome , 161, Italy
Torino , , Italy
Białystok , 15-74, Poland
Bydgoszcz , 85-16, Poland
Gdańsk , 80-21, Poland
Gdańsk , 80-21, Poland
Toruń , , Poland
Warsaw , 02-77, Poland
Wrocław , 50-36, Poland
Łódź , 93-51, Poland
Barnaul , , Russian Federation
Ekaterinburg , 62010, Russian Federation
Kemerovo , 65006, Russian Federation
Moscow , 12528, Russian Federation
Moscow , , Russian Federation
Nizhny Novgorod , 60312, Russian Federation
Novosibirsk , , Russian Federation
Petrozavodsk , 18501, Russian Federation
Rostov-on-Don , , Russian Federation
Saint Petersburg , 19102, Russian Federation
Samara , 44309, Russian Federation
Tomsk , 63406, Russian Federation
Tula , 30005, Russian Federation
Ufa , , Russian Federation
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