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

Locations

Arms

47.9

Anticipated Duration (Months)

4.5

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 Disease	Intervention/Treatment	Phase
Chronic Lymphocytic Leukemia Hypogammaglobulinemia	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 :

Oct 1, 2024

Anticipated Study Completion Date :

Oct 1, 2024

Arms and Interventions

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

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

Primary Outcome Measures

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, 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

Overall infection rate [52 weeks]
Infection rate for all infections
Frequency of prophylaxis with anti-infectives [52 weeks]
Inclusive of antibacterials and antivirals
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:

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] <30 mL/min/1.73 m2).
Body weight >140 kg.
Eastern Cooperative Oncology Group (ECOG) performance score of >2 (Appendix 1).
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.
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.
Known IgA deficiency with antibodies to IgA.
Known blood hyperviscosity, or other hypercoagulable states.
Patients unable or unwilling to understand or comply with the study protocol.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Octapharma Research Site	Saint Petersburg	Florida	United States	33709
2	Octapharma Research Site	Baltimore	Maryland	United States	21224
3	Octapharma Research Site	Detroit	Michigan	United States	48093
4	Octapharma Research Site	Rochester	Minnesota	United States	55902
5	Octapharma Research Site	New York	New York	United States	10032
6	Octapharma Research Site	New York	New York	United States	10065
7	Octapharma Research Site	Durham	North Carolina	United States	27710
8	Octapharma Research Site	Houston	Texas	United States	77090
9	Octapharma Research Site	Aalborg		Denmark	9000
10	Octapharma Research Site	Holstebro		Denmark	7500
11	Octapharma Research Site	Roskilde		Denmark	4000
12	Octapharma Research Site	Dortmund		Germany	44263
13	Octapharma Research Site	Frankfurt		Germany	15236
14	Octapharma Research Site	Frechen		Germany	50226
15	Octapharma Research Site	Goslar		Germany	38642
16	Octapharma Research Site	Kiel		Germany	24105
17	Octapharma Research Site	Marburg		Germany	35037
18	Octapharma Research Site	Budapest		Hungary	1083
19	Octapharma Research Site	Debrecen		Hungary	4032
20	Octapharma Research Site	Győr		Hungary	H-9024
21	Octapharma Research Site	Kaposvár		Hungary	7400
22	Octapharma Research Site	Nyiregyhaza		Hungary	4400
23	Octapharma Research Site	Haifa		Israel
24	Octapharma Research Site	Petah tikva		Israel
25	Octapharma Research Site	Tel Aviv		Israel
26	Octapharma Research Site	Milano		Italy	20132
27	Octapharma Research Site	Milano		Italy	20162
28	Octapharma Research Site	Orbassano		Italy
29	Octapharma Research Site	Padova		Italy	35128
30	Octapharma Research Site	Reggio Calabria		Italy
31	Octapharma Research Site	Rome		Italy	161
32	Octapharma Research Site	Torino		Italy
33	Octapharma Research Site	Białystok		Poland	15-748
34	Octapharma Research Site	Bydgoszcz		Poland	85-168
35	Octapharma Research Site	Gdańsk		Poland	80-214
36	Octapharma Research Site	Gdańsk		Poland	80-219
37	Octapharma Research Site	Warsaw		Poland	02-776
38	Octapharma Research Site	Wrocław		Poland	50-367
39	Octapharma Research Site	Łódź		Poland	93-513
40	Octapharma Research Site	Barnaul		Russian Federation
41	Octapharma Research Site	Ekaterinburg		Russian Federation	620102
42	Octapharma Research Site	Kemerovo		Russian Federation	650066
43	Octapharma Research Site	Moscow		Russian Federation	125284
44	Octapharma Research Site	Moscow		Russian Federation
45	Octapharma Research Site	Nizhny Novgorod		Russian Federation	603126
46	Octapharma Research Site	Novosibirsk		Russian Federation
47	Octapharma Research Site	Petrozavodsk		Russian Federation	185019
48	Octapharma Research Site	Rostov-on-Don		Russian Federation
49	Octapharma Research Site	Saint Petersburg		Russian Federation	191024
50	Octapharma Research Site	Samara		Russian Federation	443099
51	Octapharma Research Site	Tomsk		Russian Federation	634063
52	Octapharma Research Site	Tula		Russian Federation	300053
53	Octapharma Research Site	Ufa		Russian 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:

Aug 11, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Leukemia

Leukemia, Lymphoid

Leukemia, Lymphocytic, Chronic, B-Cell

Agammaglobulinemia

Study Results

No Results Posted as of Aug 11, 2022