CompletedPhase 3

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)

United States247 participantsStarted 2020-10-05

Plain-language summary

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

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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).

Occurrence of major infections

Timeframe: 52 weeks

NCT IDNCT04502030

SponsorOctapharma

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-09-19

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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).