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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)

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ClinicalTrials.gov Identifier: NCT04502030
Recruitment Status : Recruiting
First Posted : August 6, 2020
Last Update Posted : April 9, 2024
Sponsor:
Information provided by (Responsible Party):
Octapharma

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

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Hypogammaglobulinemia Biological: Panzyga Other: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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)
Actual Study Start Date : October 5, 2020
Estimated Primary Completion Date : August 2025
Estimated Study Completion Date : August 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Panzyga Biological: Panzyga
Panzyga is a 10% IVIG produced from a pool of human fresh frozen plasma donations
Placebo Comparator: Placebo Other: Placebo
Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Occurrence of major infections [ Time Frame: 52 weeks ]

    Major infection for this trial is defined as:

    • Bacterial and/or viral infections resulting in death
    • 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, localized skin infections and stomatitis (MDI or CDI) are considered major only if they require treatment with antiinfectives AND hospitalization or hospitalization prolongation.
    • Fever of unknown origin (FUO) requiring hospitalization or hospitalization prolongation


Secondary Outcome Measures :
  1. Overall infection rate [ Time Frame: 52 weeks ]
    Infection rate for all infections

  2. Frequency of prophylaxis with anti-infectives [ Time Frame: 52 weeks ]
    Inclusive of antibacterials and antivirals

  3. Duration of prophylaxis with anti-infectives [ Time Frame: 52 weeks ]
    Inclusive of antibacterials and antivirals


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 <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.

Exclusion Criteria:

  1. IgG treatment within 3 months prior to Screening.
  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.
  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 m2).
  8. Body weight >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 (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.
  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.
  19. Known blood hyperviscosity, or other hypercoagulable states.
  20. Patients unable or unwilling to understand or comply with the study protocol.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04502030


Contacts
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Contact: Patrick M Murphy 8663371868 ctgov@clinicalresearchmgt.com

Locations
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Sponsors and Collaborators
Octapharma
More Information
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Responsible Party: Octapharma
ClinicalTrials.gov Identifier: NCT04502030    
Other Study ID Numbers: NGAM-12
First Posted: August 6, 2020    Key Record Dates
Last Update Posted: April 9, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Agammaglobulinemia
Neoplasms by Histologic Type
Neoplasms
Hematologic Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
 Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Chronic Disease
Disease Attributes
Pathologic Processes
Blood Protein Disorders
Immunologic Deficiency Syndromes