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)

Phase 1

• Conditions: Primary infection prophylaxis in patients with chronic lymphocytic leukemia (CLL) and secondary hypogammaglobulinemia; MedDRA version: 21.0Level: LLTClassification code 10008976Term: Chronic lymphocytic leukemiaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-004375-40-IT
• Lead Sponsor: OCTAPHARMA PHARMAZEUTIKA PRODUKTIONSGES.M.B.H.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-17
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 450

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 225
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 225

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 trimethoprimsulfamethoxazole
[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 protocolrequired
method of contraception 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 positivesurface 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified