A Study to Evaluate the Effectiveness and Safety of Panzyga in Patients with Chronic Lymphocytic Leukemia

Overview

About this study

The purpose of this study is to demonstrate the benefit of Panzyga administration compared with placebo as primary infection prophylaxis in Chronic Lymphocytic Leukemia (CLL) patients with secondary immunodeficiency (SID) undergoing CLL antineoplastic therapy.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • 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 Criteria:

  • 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] 140 kg.
  • Eastern Cooperative Oncology Group (ECOG) performance score of > 2.
  • 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.
  • 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.

Eligibility last updated 3/18/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Wei Ding, M.B.B.S., Ph.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available
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CLS-20488337

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