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| ID | Type | Description | Link |
|---|---|---|---|
| MTS-93-726-ME | |||
| MTS-FDR001162 |
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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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEG-interleukin-2 | Drug |
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
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| Name | Affiliation | Role |
|---|---|---|
| Charlotte Cunningham-Rundles | Icahn School of Medicine at Mount Sinai | Study Chair |
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| ID | Term |
|---|---|
| D017074 | Common Variable Immunodeficiency |
| D007154 | Immune System Diseases |
| D003141 | Communicable Diseases |
| D000081207 | Primary Immunodeficiency Diseases |
| D035583 | Rare Diseases |
| ID | Term |
|---|---|
| D007153 | Immunologic Deficiency Syndromes |
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| C067245 | interleukin-2, polyethylene glycol-modified |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |