Loading clinical trials...

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) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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)

NCT04502030•Octapharma

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+10 more criteria

Locations (84)

Octapharma Research Site

St. Petersburg, Florida, United States

Octapharma Research Site

Columbus, Georgia, United States

Octapharma Research Site

Macon, Georgia, United States

Octapharma Research Site

New Orleans, Louisiana, United States

Octapharma Research Site

Baltimore, Maryland, United States

Octapharma Research Site

Baltimore, Maryland, United States

Octapharma Research Site

Detroit, Michigan, United States

Octapharma Research Site

Rochester, Minnesota, United States

Octapharma Research Site

Buffalo, New York, United States

Octapharma Research Site

New York, New York, United States

Key Dates

Start Date

October 5, 2020

Primary Completion Date

September 19, 2025

Completion Date

September 19, 2025

Last Updated

October 3, 2025

Enrollment

247

ACTUAL participants

Conditions

Chronic Lymphocytic LeukemiaHypogammaglobulinemia

Interventions

Panzyga

BIOLOGICAL

Placebo

OTHER

A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies

NCT05006716

B-cell MalignancyMarginal Zone Lymphoma+7 more

View study

RECRUITINGPHASE3

A Study to Investigate Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Adults With Previously Untreated Chronic Lymphocytic Leukemia

NCT07277231

Chronic Lymphocytic Leukemia

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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)

Inclusion Criteria

Exclusion Criteria

A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies

A Study to Investigate Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Adults With Previously Untreated Chronic Lymphocytic Leukemia

A Platform Protocol to Investigate Post-Transplant Cyclophosphamide-Based Graft-Versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies Undergoing Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation

A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

A Long-term Extension Study of PCI-32765 (Ibrutinib)

Economic Analysis of Early vs Delayed Therapy in Newly Diagnosed Asymptomatic High-Risk Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma: