drugset / Trial / NCT00573378

Imatinib or Nilotinib With Pegylated Interferon-α2b in Chronic Myeloid Leukemia

NCT00573378

Phase 2 Terminated 12 enrolled University of Michigan Rogel Cancer Center
NaSingle-groupOpen-labelTreatment

Summary

To investigate whether patients with chronic-phase chronic myeloid leukemia (CP-CML) who have achieved a complete cytogenetic response (CCyR) on imatinib (IM) or nilotinib (N) can then be treated with a combination of the tyrosine kinase inhibitor (TKI) and interferon-α2b (PEG-IFN-a2b, \[IFN\]) for 2 years, subsequently have their therapy discontinued, and then maintain a durable molecular response off all therapy. Relapse-free survival (RFS) rate 1 year after discontinuation of the TKI and IFN will be the measurement of this objective.

Timeline

Start
2007-09
Primary completion
2010-10
Completion
2015-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Peginterferon alfa-2b Protein / enzyme biologic 150 ug Subcutaneous