Status:
COMPLETED
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)
Lead Sponsor:
Octapharma
Conditions:
Chronic Lymphocytic Leukemia
Hypogammaglobulinemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Study Evaluating Efficacy and Safety of Panzyga in Primary Infection Prophylaxis in Patients with Chronic Lymphocytic Leukemia
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 19 2025
Estimated Enrollment :
247 Patients enrolled
Trial Details
Trial ID
NCT04502030
Start Date
October 5 2020
End Date
September 19 2025
Last Update
October 3 2025
Active Locations (84)
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1
Octapharma Research Site
St. Petersburg, Florida, United States, 33709
2
Octapharma Research Site
Columbus, Georgia, United States, 31904
3
Octapharma Research Site
Macon, Georgia, United States, 31201
4
Octapharma Research Site
New Orleans, Louisiana, United States, 70112