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)

Sponsor
Octapharma (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04502030
Collaborator
(none)
240
Enrollment
48
Locations
2
Arms
34.9
Anticipated Duration (Months)
5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or DiseaseIntervention/TreatmentPhase
  • Biological: Panzyga
  • Other: Placebo
Phase 3

Study Design

Study Type:
Interventional
Anticipated 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 :
Oct 5, 2020
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

ArmIntervention/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

Primary Outcome Measures

  1. Occurrence of major infections [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, bacterial 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 [52 weeks]

    Infection rate for all infections

  2. Frequency of prophylaxis with anti-infectives [52 weeks]

    Inclusive of antibacterials and antivirals

  3. Duration of prophylaxis with anti-infectives [52 weeks]

    Inclusive of antibacterials and antivirals

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 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] <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

Locations

SiteCityStateCountryPostal Code
1Octapharma Research SiteRochesterMinnesotaUnited States55902
2Octapharma Research SiteNew YorkNew YorkUnited States10032
3Octapharma Research SiteNew YorkNew YorkUnited States10065
4Octapharma Research SiteDurhamNorth CarolinaUnited States27710
5Octapharma Research SiteHoustonTexasUnited States77090
6Octapharma Research SiteAalborgDenmark9000
7Octapharma Research SiteHolstebroDenmark7500
8Octapharma Research SiteRoskildeDenmark4000
9Octapharma Research SiteDortmundGermany44263
10Octapharma Research SiteFrankfurtGermany15236
11Octapharma Research SiteFrechenGermany50226
12Octapharma Research SiteGoslarGermany38642
13Octapharma Research SiteKielGermany24105
14Octapharma Research SiteMarburgGermany35037
15Octapharma Research SiteBudapestHungary1083
16Octapharma Research SiteDebrecenHungary4032
17Octapharma Research SiteGyőrHungaryH-9024
18Octapharma Research SiteKaposvárHungary7400
19Octapharma Research SiteNyiregyhazaHungary4400
20Octapharma Research SiteHaifaIsrael
21Octapharma Research SitePetah tikvaIsrael
22Octapharma Research SiteTel AvivIsrael
23Octapharma Research SiteMilanoItaly20132
24Octapharma Research SiteMilanoItaly20162
25Octapharma Research SitePadovaItaly35128
26Octapharma Research SiteRomeItaly161
27Octapharma Research SiteTorinoItaly
28Octapharma Research SiteBiałystokPoland15-748
29Octapharma Research SiteBydgoszczPoland85-168
30Octapharma Research SiteGdańskPoland80-214
31Octapharma Research SiteGdańskPoland80-219
32Octapharma Research SiteWarsawPoland02-776
33Octapharma Research SiteWrocławPoland50-367
34Octapharma Research SiteŁódźPoland93-513
35Octapharma Research SiteBarnaulRussian Federation
36Octapharma Research SiteEkaterinburgRussian Federation620102
37Octapharma Research SiteKemerovoRussian Federation650066
38Octapharma Research SiteMoscowRussian Federation125284
39Octapharma Research SiteMoscowRussian Federation
40Octapharma Research SiteNizhny NovgorodRussian Federation603126
41Octapharma Research SiteNovosibirskRussian Federation
42Octapharma Research SitePetrozavodskRussian Federation185019
43Octapharma Research SiteRostov-on-DonRussian Federation
44Octapharma Research SiteSaint PetersburgRussian Federation191024
45Octapharma Research SiteSamaraRussian Federation443099
46Octapharma Research SiteTomskRussian Federation634063
47Octapharma Research SiteTulaRussian Federation300053
48Octapharma Research SiteUfaRussian Federation

Sponsors and Collaborators

  • Octapharma

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Octapharma
ClinicalTrials.gov Identifier:
NCT04502030
Other Study ID Numbers:
  • NGAM-12
First Posted:
Aug 6, 2020
Last Update Posted:
Dec 28, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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:

Study Results

No Results Posted as of Dec 28, 2021