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)

Summary

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

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 3

Estimated Enrollment:

240

Study ID:

NCT04502030

Recruitment Status:

Recruiting

Sponsor:

Octapharma

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There are 80 Locations for this study

See Locations Near You

Octapharma Research Site
Saint Petersburg Florida, 33709, United States
Octapharma Research Site
Columbus Georgia, 31904, United States
Octapharma Research Site
Macon Georgia, 31201, United States
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New Orleans Louisiana, 70112, United States
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Baltimore Maryland, 21201, United States
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Baltimore Maryland, 21205, United States
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Detroit Michigan, 48093, United States
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Rochester Minnesota, 55902, United States
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Buffalo New York, 14260, United States
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New York New York, 10032, United States
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New York New York, 10065, United States
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Durham North Carolina, 27710, United States
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Charleston South Carolina, 29414, United States
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Houston Texas, 77090, United States
Octapharma Research Site
Brno , 625 0, Czechia
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Hradec Králové , 500 0, Czechia
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Ostrava , 70852, Czechia
Octapharma Research Site
Aalborg , 9000, Denmark
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Herning , 7400, Denmark
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Roskilde , 4000, Denmark
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Dortmund , 44263, Germany
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Frankfurt , 15236, Germany
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Kiel , 24105, Germany
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Marburg , 35037, Germany
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Athens , 10676, Greece
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Athens , 11526, Greece
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Athens , 12462, Greece
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Ioánnina , 45500, Greece
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Patras , 26500, Greece
Octapharma Research Site
Thessaloníki , 57010, Greece
Octapharma Research Site
Budapest , 1088, Hungary
Octapharma Research Site
Debrecen , 4032, Hungary
Octapharma Research Site
Győr , 9023, Hungary
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Kaposvár , 7400, Hungary
Octapharma Research Site
Nyiregyhaza , 4400, Hungary
Octapharma Research Site
Haifa , 31096, Israel
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Haifa , 34362, Israel
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Petah tikva , 49100, Israel
Octapharma Research Site
Tel Aviv , 64239, Israel
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Castelfranco Veneto , 31033, Italy
Octapharma Research Site
Milano , 20132, Italy
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Milano , 20162, Italy
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Modena , 41124, Italy
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Orbassano , 10043, Italy
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Padova , 35129, Italy
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Pescara , 65124, Italy
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Reggio Calabria , 89133, Italy
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Rome , 00161, Italy
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Torino , 10126, Italy
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Białystok , 15-74, Poland
Octapharma Research Site
Bydgoszcz , 85-06, Poland
Octapharma Research Site
Gdańsk , 80-21, Poland
Octapharma Research Site
Gdańsk , 80-21, Poland
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Gdynia , 81-51, Poland
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Katowice , 40-51, Poland
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Legnica , 59-22, Poland
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Toruń , 87-10, Poland
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Warsaw , 02-77, Poland
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Wrocław , 50-36, Poland
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Łódź , 93-51, Poland
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Barnaul , , Russian Federation
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Ekaterinburg , 62010, Russian Federation
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Kemerovo , 65006, Russian Federation
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Moscow , 11547, Russian Federation
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Moscow , 12528, Russian Federation
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Nizhny Novgorod , 60312, Russian Federation
Octapharma Research Site
Novosibirsk , 63005, Russian Federation
Octapharma Research Site
Petrozavodsk , 18501, Russian Federation
Octapharma Research Site
Rostov-on-Don , 34403, Russian Federation
Octapharma Research Site
Saint Petersburg , 19102, Russian Federation
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Samara , 44307, Russian Federation
Octapharma Research Site
Tomsk , 63406, Russian Federation
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Tula , 30005, Russian Federation
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Ufa , 45000, Russian Federation
Octapharma Research Site
Madrid , 28034, Spain
Octapharma Research Site
Madrid , 28040, Spain
Octapharma Research Site
Madrid , 28046, Spain
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Oviedo , 33011, Spain
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Santander , 39008, Spain
Octapharma Research Site
Cebeci/Ankara , 65900, Turkey
Octapharma Research Site
Fatih/Istanbul , 34093, Turkey
Octapharma Research Site
Kazimdirik , 35100, Turkey
Octapharma Research Site
Melikgazi/Kayseri , 38039, Turkey

How clear is this clinincal trial information?

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 3

Estimated Enrollment:

240

Study ID:

NCT04502030

Recruitment Status:

Recruiting

Sponsor:


Octapharma

How clear is this clinincal trial information?

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