Randomized Study of Polyethylene-Glycol-Conjugated Interleukin 2 in Patients With Common Variable Immunodeficiency

Icahn School of Medicine at Mount Sinai48 enrolled

Overview

OBJECTIVES: I. Determine whether polyethylene-glycol-conjugated interleukin 2 (PEG-IL-2) can reduce the number of infections in patients with common variable immunodeficiency. II. Determine whether this therapy can improve lung functions in these patients with pulmonary impairment.

PROTOCOL OUTLINE: This is a randomized, open-label study. Patients are randomized to receive polyethylene-glycol-conjugated interleukin 2 (PEG-IL-2) or placebo. Patients receive PEG-IL-2 or placebo by subcutaneous injection weekly for 18 months. Patients maintain a daily diary for 24 months. Patients are followed every 4 months for 2 years. Completion date provided represents the completion date of the grant per OOPD records

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Common Variable Immunodeficiency

Interventions

PEG-interleukin-2DRUG

Eligibility

Sex: ALLMin age: 2 Years

Medical Language ↔ Plain English

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Documented common variable immunodeficiency defined as a reduction of serum IgG by at least 2 standard deviations In vitro lymphocyte proliferative response to PEG-IL-2 of at least 10 times more than unstimulated cultures --Prior/Concurrent Therapy-- No biologic response modifier therapy (i.e., interferon, cyclosporin A) except prednisone (maximum 10 mg/day) Concurrent treatment with same dosage intravenous gamma-globulin for at least 6 months is required --Patient Characteristics-- Life expectancy: At least 24 months Other: Not pregnant or nursing HIV negative

Data from ClinicalTrials.gov

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