A Phase II Open Label Study to Determine Safety and Efficacy of Interferon-alpha in Combination With Imantinib Mesylate (Gleevec) in Patients With Chronic Phase Chronic Myelogenous Leukemia Who Have Not Achieved a Complete Cytogenetic Response to Gleevec as a Single Agent
- Determine whether interferon alfa in combination with imatinib mesylate adds to the
hematologic, cytogenetic, and molecular response rates in patients with chronic phase
chronic myelogenous leukemia that is newly diagnosed or has not achieved a complete
cytogenetic response to imatinib mesylate alone.
OUTLINE: Patients receive oral imatinib mesylate (STI-571) once daily for 9 months. At 9
months, patients with more than 35% Philadelphia chromosome-positive (Ph+) cells in bone
marrow receive oral STI-571 twice daily for 3 more months. At 12 months, patients with more
than 35% Ph+ cells in bone marrow receive oral STI-571 once daily and interferon alfa
subcutaneously once daily. Treatment continues for at least 1 year in the absence of disease
progression or unacceptable toxicity. Patients with an appropriate HLA-matched donor may
choose to have a bone marrow transplantation at any time during the study.
Patients are followed every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 80 patients (60 without an HLA-matched donor and 20 with an
HLA-matched donor) will be accrued for this study within 5 years.
Masking: Open Label, Primary Purpose: Treatment
Ellin Berman, MD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|