Double-blind (neither the patient nor the doctor knows treatment allocation of the patient), randomized, placebo-controlled, prospective phase III clinical study to evaluate the efficacy and safety of Panzyga in infection prevention in patients with a specific type of cancer, cancer of the blood and bone marrow (Chronic Lymphocytic Leukemia) (PRO-SID study).
- Conditions
- Primary infection prophylaxis in patients with chronic lymphocytic leukemia (CLL) and secondary hypogammaglobulinemia.MedDRA version: 21.0Level: LLTClassification code: 10008976Term: Chronic lymphocytic leukemia Class: 10029104Therapeutic area: Diseases [C] - Neoplasms [C04]
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 240
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.
1. IgG treatment within 3 months prior to Screening., 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 m 2)., 8. Body weight >140 kg., 9. Eastern Cooperative Oncology Group (ECOG) performance score of >2 (Appendix1)., 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 (as part of the patient´s medical history)., 19. Known blood hyperviscosity, or other hypercoagulable states., 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., 20. Patients unable or unwilling to understand or comply with the study protocol., 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))., 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this study is to demonstrate the benefit of Panzyga administration compared with placebo as primary infection prophylaxis in CLL patients with secondary<br>immunodeficiency (SID) undergoing CLL antineoplastic therapy.;Secondary Objective: The secondary objectives of this study are to compare the following aspects in CLL patients with SID treated with and without primary Panzyga prophylaxis: - Overall infection rate - Frequency of prophylaxis with anti-infectives (antibacterials and antivirals) - Duration of prophylaxis with anti-infectives (antibacterials and antivirals);Primary end point(s): Since the study objective is to show the benefit of Panzyga administration as primary infection prophylaxis, the primary endpoint is not the major infection rate but occurrence of at least one major infection in CLL patients with or without primary infection prophylaxis with Panzyga. Please refer to the Protocol for more information on the Primary endpoint.
- Secondary Outcome Measures
Name Time Method Secondary end point(s):1. Overall infection rate: infection rate for all infections.;Secondary end point(s):2. Frequency of prophylaxis with anti-infectives (antibacterials and antivirals).;Secondary end point(s):3. Duration of prophylaxis with anti-infectives (antibacterials and antivirals).