drugset / Trial / NCT01387763
A Study of Low Dose Interferon Alpha Versus Hydroxyurea in Treatment of Chronic Myeloid Neoplasms
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of the study is to compare the efficacy and toxicity including quality of life of two types of low-dose interferon alpha compounds (PegIntron and Pegasys) with hydroxyurea (Hydrea), and to investigate the occurence of neutralizing antibodies against recombinant interferon.
Timeline
- Start
- 2012-01
- Primary completion
- 2020-06
- Completion
- 2020-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Hydroxyurea | Other / unclassified | 500 mg | Oral |
| Comparator | Hydroxyurea | Other / unclassified | 2000 mg | Oral |
| Comparator | Peginterferon alfa-2a | Protein / enzyme biologic | 45 ug | Subcutaneous |
| Comparator | Peginterferon alfa-2a | Protein / enzyme biologic | 90 ug | Subcutaneous |
| Comparator | Peginterferon alfa-2a | Protein / enzyme biologic | 135 ug | Subcutaneous |
| Comparator | Peginterferon alfa-2b | Protein / enzyme biologic | 30 ug | Subcutaneous |
| Comparator | Peginterferon alfa-2b | Protein / enzyme biologic | 35 ug | Subcutaneous |
| Comparator | Peginterferon alfa-2b | Protein / enzyme biologic | 50 ug | Subcutaneous |
| Comparator | Peginterferon alfa-2b | Protein / enzyme biologic | 96 ug | Subcutaneous |