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)
Completed · Phase 3 · Has a placebo group
Conditions studied: Chronic Lymphocytic Leukemia, Hypogammaglobulinemia
In brief
Study Evaluating Efficacy and Safety of Panzyga in Primary Infection Prophylaxis in Patients with Chronic Lymphocytic Leukemia
Key facts
- Study ID
- NCT04502030
- Run by
- Octapharma
- People needed
- 247
- Starts
- 2020-10-05
- Expected to finish
- 2025-09-19
- Last updated by the study team
- 2026-06-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
- 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.
You may not qualify if…
- 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.
Where it is running
- Octapharma Research Site — Columbus, Georgia, United States
- Octapharma Research Site — Macon, Georgia, United States
- Octapharma Research Site — New Orleans, Louisiana, United States
- Octapharma Research Site — Baltimore, Maryland, United States
- Octapharma Research Site — Baltimore, Maryland, United States
- Octapharma Research Site — Detroit, Michigan, United States
- Octapharma Research Site — Rochester, Minnesota, United States
- Octapharma Research Site — Buffalo, New York, United States
- Octapharma Research Site — New York, New York, United States
- Octapharma Research Site — New York, New York, United States
- Octapharma Research Site — Shirley, New York, United States
- Octapharma Research Site — Durham, North Carolina, United States
- Octapharma Research Site — Charleston, South Carolina, United States
- Octapharma Research Site — Houston, Texas, United States
- Octapharma Research Site — Brno, Czechia
- Octapharma Research Site — Hradec Králové, Czechia
- Octapharma Research Site — Ostrava, Czechia
- Octapharma Research Site — Aalborg, Denmark
- Octapharma Research Site — Herning, Denmark
- Octapharma Research Site — Roskilde, Denmark
- Octapharma Research Site — Dortmund, Germany
- Octapharma Research Site — Frankfurt, Germany
- Octapharma Research Site — Kiel, Germany
- Octapharma Research Site — Marburg, Germany
- Octapharma Research Site — St. Petersburg, Florida, United States
Full record on ClinicalTrials.gov
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