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)

NCT03547154 ↗

Phase 2/3 Terminated 344 enrolled Merck Sharp & Dohme LLC
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

EvaluationDrugModalityDoseRoute
Subject Pegylated interferon alfa-2b Protein / enzyme biologic 6 ug/kg Subcutaneous
Subject interferon alfa-2b Protein / enzyme biologic 5 unknown Subcutaneous