drugset / Trial / NCT03547154
Polyethylene Glycol Interferon Alfa-2b (PEG Intron) Versus Interferon Alfa-2b (INTRON^® A) in the Treatment of Newly Diagnosed Chronic Myelogenous Leukemia (CML) (C98026)
RandomizedParallel-groupOpen-labelTreatment
Summary
The primary purpose of this study is to compare the efficacy of polyethylene glycol (PEG; pegylated) interferon alfa-2b (PEG Intron, C98026) versus interferon alfa-2b (Intron® A) in the treatment of participants with newly diagnosed CML.
Timeline
- Start
- 1998-10-22
- Primary completion
- 2001-02-20
- Completion
- 2001-02-20
Outcome
Missed primary endpoint
registry analysis (superiority or other test); INTRON A (Interferon Alfa-2b) vs PEG Intron (Pegylated Interferon Alfa-2b); p = 0.322; Fisher Exact; note: Analysis of Major Response NCT03547154 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pegylated interferon alfa-2b | Protein / enzyme biologic | 6 ug/kg | Subcutaneous |
| Subject | interferon alfa-2b | Protein / enzyme biologic | 5 unknown | Subcutaneous |