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
50
Locations
2
Arms
73.9
Anticipated Duration (Months)
4.8
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 :
Dec 1, 2026
Anticipated Study Completion Date :
Dec 1, 2026

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 SiteSaint PetersburgFloridaUnited States33709
2Octapharma Research SiteRochesterMinnesotaUnited States55902
3Octapharma Research SiteNew YorkNew YorkUnited States10032
4Octapharma Research SiteNew YorkNew YorkUnited States10065
5Octapharma Research SiteDurhamNorth CarolinaUnited States27710
6Octapharma Research SiteHoustonTexasUnited States77090
7Octapharma Research SiteAalborgDenmark9000
8Octapharma Research SiteHolstebroDenmark7500
9Octapharma Research SiteRoskildeDenmark4000
10Octapharma Research SiteDortmundGermany44263
11Octapharma Research SiteFrankfurtGermany15236
12Octapharma Research SiteFrechenGermany50226
13Octapharma Research SiteGoslarGermany38642
14Octapharma Research SiteKielGermany24105
15Octapharma Research SiteMarburgGermany35037
16Octapharma Research SiteBudapestHungary1083
17Octapharma Research SiteDebrecenHungary4032
18Octapharma Research SiteGyőrHungaryH-9024
19Octapharma Research SiteKaposvárHungary7400
20Octapharma Research SiteNyiregyhazaHungary4400
21Octapharma Research SiteHaifaIsrael
22Octapharma Research SiteHaifaIsrael
23Octapharma Research SitePetah tikvaIsrael
24Octapharma Research SiteTel AvivIsrael
25Octapharma Research SiteMilanoItaly20132
26Octapharma Research SiteMilanoItaly20162
27Octapharma Research SitePadovaItaly35128
28Octapharma Research SiteRomeItaly161
29Octapharma Research SiteTorinoItaly
30Octapharma Research SiteBiałystokPoland15-748
31Octapharma Research SiteBydgoszczPoland85-168
32Octapharma Research SiteGdańskPoland80-214
33Octapharma Research SiteGdańskPoland80-219
34Octapharma Research SiteWarsawPoland02-776
35Octapharma Research SiteWrocławPoland50-367
36Octapharma Research SiteŁódźPoland93-513
37Octapharma Research SiteBarnaulRussian Federation
38Octapharma Research SiteEkaterinburgRussian Federation620102
39Octapharma Research SiteKemerovoRussian Federation650066
40Octapharma Research SiteMoscowRussian Federation125284
41Octapharma Research SiteMoscowRussian Federation
42Octapharma Research SiteNizhny NovgorodRussian Federation603126
43Octapharma Research SiteNovosibirskRussian Federation
44Octapharma Research SitePetrozavodskRussian Federation185019
45Octapharma Research SiteRostov-on-DonRussian Federation
46Octapharma Research SiteSaint PetersburgRussian Federation191024
47Octapharma Research SiteSamaraRussian Federation443099
48Octapharma Research SiteTomskRussian Federation634063
49Octapharma Research SiteTulaRussian Federation300053
50Octapharma 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:
Mar 10, 2022
Last Verified:
Mar 1, 2022
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 Mar 10, 2022