Chronic Lymphocytic LeukemiaPhase 3NCT04502030
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)
A Phase 3 study testing Panzyga in people with Chronic Lymphocytic Leukemia and Hypogammaglobulinemia, run by Octapharma at 84 sites in 12 countries.
Trial summary
Study Evaluating Efficacy and Safety of Panzyga in Primary Infection Prophylaxis in Patients with Chronic Lymphocytic Leukemia Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia, Hypogammaglobulinemia
- What is being tested?
- Panzyga
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 247 participants
- Where
- 84 sitesin 12 countries
- Study dates
- 5 Oct 2020to 19 Sep 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
84 sites in 12 countries.
84 sites in 12 countries
United States15 sites
Octapharma Research Site
Baltimore, Maryland, 21201
Octapharma Research Site
Baltimore, Maryland, 21205
Octapharma Research Site
Buffalo, New York, 14260
Octapharma Research Site
Charleston, South Carolina, 29414
Octapharma Research Site
Columbus, Georgia, 31904
Octapharma Research Site
Detroit, Michigan, 48093
Octapharma Research Site
Durham, North Carolina, 27710
Octapharma Research Site
Houston, Texas, 77090
Octapharma Research Site
Macon, Georgia, 31201
Octapharma Research Site
New Orleans, Louisiana, 70112
Octapharma Research Site
New York, New York, 10032
Octapharma Research Site
New York, New York, 10065
Octapharma Research Site
Rochester, Minnesota, 55902
Octapharma Research Site
Shirley, New York, 11967
Octapharma Research Site
St. Petersburg, Florida, 33709
Russia14 sites
Octapharma Research Site
Barnaul, 656024
Octapharma Research Site
Kemerovo, 650066
Octapharma Research Site
Moscow, 115478
Octapharma Research Site
Moscow, 125284
Octapharma Research Site
Nizhny Novgorod, 603126
Octapharma Research Site
Novosibirsk, 630051
Octapharma Research Site
Petrozavodsk, 185019
Octapharma Research Site
Rostov-on-Don, 344037
Octapharma Research Site
Saint Petersburg, 191024
Octapharma Research Site
Samara, 443079
Octapharma Research Site
Tomsk, 634063
Octapharma Research Site
Tula, 300053
Octapharma Research Site
Ufa, 450008
Octapharma Research Site
Yekaterinburg, 620102
Poland11 sites
Octapharma Research Site
Bialystok, 15-732
Octapharma Research Site
Bydgoszcz, 85-065
Octapharma Research Site
Gdansk, 80-214
Octapharma Research Site
Gdansk, 80-219
Octapharma Research Site
Gdynia, 81-519
Octapharma Research Site
Katowice, 40-519
Octapharma Research Site
Legnica, 59-220
Octapharma Research Site
Lodz, 93-513
Octapharma Research Site
Torun, 87-100
Octapharma Research Site
Warsaw, 02-776
Octapharma Research Site
Wroclaw, 50-367
Italy10 sites
Octapharma Research Site
Castelfranco Veneto, 31033
Octapharma Research Site
Milan, 20132
Octapharma Research Site
Milan, 20162
Octapharma Research Site
Modena, 41124
Octapharma Research Site
Orbassano, 10043
Octapharma Research Site
Padova, 35129
Octapharma Research Site
Pescara, 65124
Octapharma Research Site
Reggio Calabria, 89133
Octapharma Research Site
Rome, 00161
Octapharma Research Site
Torino, 10126
Greece6 sites
Octapharma Research Site
Athens, 10676
Octapharma Research Site
Athens, 11526
Octapharma Research Site
Athens, 12462
Octapharma Research Site
Ioannina, 45500
Octapharma Research Site
Pátrai, 26500
Octapharma Research Site
Thessaloniki, 57010
Hungary5 sites
Octapharma Research Site
Budapest, 1088
Octapharma Research Site
Debrecen, 4032
Octapharma Research Site
Győr, 9023
Octapharma Research Site
Kaposvár, 7400
Octapharma Research Site
Nyíregyháza, 4400
Spain5 sites
Octapharma Research Site
Madrid, 28034
Octapharma Research Site
Madrid, 28040
Octapharma Research Site
Madrid, 28046
Octapharma Research Site
Oviedo, 33011
Octapharma Research Site
Santander, 39008
Turkey (Türkiye)5 sites
Octapharma Research Site
Ankara, 65900
Octapharma Research Site
Antalya, 7050
Octapharma Research Site
Istanbul, 34093
Octapharma Research Site
Izmir, 35100
Octapharma Research Site
Kayseri, 38039
Germany4 sites
Octapharma Research Site
Dortmund, 44263
Octapharma Research Site
Frankfurt, 15236
Octapharma Research Site
Kiel, 24105
Octapharma Research Site
Marburg, 35037
Czechia3 sites
Octapharma Research Site
Brno, 625 00
Octapharma Research Site
Hradec Králové, 500 05
Octapharma Research Site
Ostrava, 70852
Denmark3 sites
Octapharma Research Site
Aalborg, 9000
Octapharma Research Site
Herning, 7400
Octapharma Research Site
Roskilde, 4000
Israel3 sites
Octapharma Research Site
Haifa, 3109601
Octapharma Research Site
Haifa, 34362
Octapharma Research Site
Petah Tikva, 49100
About this study
Study Evaluating Efficacy and Safety of Panzyga in Primary Infection Prophylaxis in Patients with Chronic Lymphocytic Leukemia
- Being tested
- Panzyga, Placebo
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Agammaglobulinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PanzygaBiological
Panzyga is a 10% IVIG produced from a pool of human fresh frozen plasma donations
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Panzyga | Experimental | Not described Receives: Biological: Panzyga |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of major infections
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
Measured: 52 weeks
Secondary outcomes (3)
Overall infection rate
Infection rate for all infections
Measured: 52 weeks
Frequency of prophylaxis with anti-infectives
Inclusive of antibacterials and antivirals
Measured: 52 weeks
Duration of prophylaxis with anti-infectives
Inclusive of antibacterials and antivirals
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2020
- Study start5 Oct 2020
- Primary completion19 Sep 2025
- Study completion19 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 247 participants (actual)
Sponsor and investigators
- Lead sponsor
- Octapharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04502030
- Sponsor's protocol ID
- NGAM-12
- Status last verified
- Oct 2025
- First submitted
- 4 Aug 2020
- Last updated
- 4 Jun 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04502030
- Acronym / sponsor ID
- NGAM-12
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 247 participants (actual)
- Lead sponsor
- OctapharmaIndustry (pharma, biotech, devices)
- Study start
- 5 Oct 2020 (actual)
- Primary completion
- 19 Sep 2025 (actual)
- Study completion
- 19 Sep 2025 (actual)
- First posted
- 6 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study Evaluating Efficacy and Safety of Panzyga in Primary Infection Prophylaxis in Patients with Chronic Lymphocytic Leukemia
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Panzyga | Experimental | Biological: Panzyga |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PanzygaPanzyga is a 10% IVIG produced from a pool of human fresh frozen plasma donations | Biological | Panzyga |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Occurrence of major infections
Time frame: 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
3 secondary outcomes
Overall infection rate
Time frame: 52 weeks
Frequency of prophylaxis with anti-infectives
Time frame: 52 weeks
Duration of prophylaxis with anti-infectives
Time frame: 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
84 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Panzyga in people with Chronic Lymphocytic Leukemia and Hypogammaglobulinemia, run by Octapharma at 84 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 84 sites in United States, Russia, Poland, Italy, Greece and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of major infections (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.