Primary infection prophylaxis in patients with chronic lymphocytic leukemia (CLL) and secondary hypogammaglobulinemia MedDRA version: 21.0 Level: LLT Classification code 10008976 Term: Chronic lymphocytic leukemia System Organ Class: 100000004864
Conditions
Sponsors
Octapharma Pharmazeutika Produktionsges.m.b.H.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 =65 years) yes F.1.3.1 Number of subjects for this age range 225
Exclusion criteria
Exclusion criteria: 1. IgG treatment within 3 months prior to Screening. 2. Antibiotic prophylaxis and/or treatment within 7 days prior to current CLL treatment start (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 with life-expectancy of less than two years. 6. Severe liver disease, with signs of ascites and/or hepatic encephalopathy. 7. Severe kidney disease (as defined by estimated glomerular filtration rate [eGFR] 140 kg. 9. Eastern Cooperative Oncology Group (ECOG) performance score of >2 (Appendix 1). 10. Female patients of childbearing potential unwilling to use a protocol-required method of contraception from the Screening Visit throughout the study treatment period and for 30 days following the last dose of study drug. 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]). 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. 20. Patients unable or unwilling to understand or comply with the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 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. Therefore, although patients will stay in the study regardless of the number of major infections, each patient will be counted only once for the primary endpoint calculation. Major infection for this trial is defined as: • Bacterial and/or viral infections resulting in death. Confirmed cases of COVID-19 are excluded. • Bacterial and/or viral infections, which are microbiologically documented (MDI) or clinically documented (CDI) requiring treatment with anti-infectives; upper respiratory tract infections, bronchitis, lower urinary tract infections, bacterial skin infections and stomatitis (MDI or CDI) are considered major only if they require treatment with anti-infectives AND hospitalization or hospitalization prolongation. Confirmed cases of COVID-19 are excluded. • FUO requiring hospitalization or hospitalization prolongation;Timepoint(s) of evaluation of this end point: Timepoint of major infection. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Overall infection rate: infection rate for all infections. • Frequency of prophylaxis with anti-infectives (antibacterials and antivirals). • Duration of prophylaxis with anti-infectives (antibacterials and antivirals).;Timepoint(s) of evaluation of this end point: • Infections throughout the study • anti-infectives frequency throughout the study • duration of prophylaxis throughout the study | — |
Countries
Czech Republic, Denmark, Germany, Hungary, Italy, Poland, Russian Federation, Spain, United States
Contacts
Public ContactGlobal Clinical Project Manager
Octapharma Pharmazeutika Produktionsges.m.b.H.
Outcome results
None listed