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)

  • STATUS
    Recruiting
  • End date
    Sep 23, 2023
  • participants needed
    240
  • sponsor
    Octapharma
Updated on 23 July 2021
chronic lymphocytic leukemia
igiv
primary infection

Summary

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

Details
Condition Chronic Lymphocytic Leukemia, Hypogammaglobulinemia, Lymphocytic Leukemia, Chronic, leukemia chronic lymphocytic, chronic lymphocytic leukemia (cll), small lymphocytic lymphoma
Treatment Placebo, Panzyga
Clinical Study IdentifierNCT04502030
SponsorOctapharma
Last Modified on23 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Treatment-nave 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 Criteria

IgG treatment within 3 months prior to Screening
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)
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 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
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