A Phase II Study of SCH 54031 (Peg Interferon Alpha-2B/PEG-Intron) in Subjects With Interferon-Refractory Chronic Myelogenous Leukemia
It has been shown that patients who experience complete hematologic or at least a partial
cytogenetic response to interferon will have improved survival times. In addition, evidence
exists that even patients who do not demonstrate a cytogenetic response to interferon
treatment can still benefit from treatment, in terms of survival, compared to patients not
treated with interferon. This indicates that if a patient is better able to tolerate
interferon, he or she may have improved survival even without cytogenetic response.
Preliminary studies suggest that PEG-Intron is more convenient for patients (administered
once weekly rather than daily), is better tolerated than interferon, and can produce
hematologic remission in interferon-a resistant patients. Phase II studies are needed to
ascertain the overall hematologic and cytogenetic response rates to PEG-Intron in such
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Razelle Kurzrock, M.D.
UT MD Anderson Cancer Center
United States: Food and Drug Administration
|M. D. Anderson Cancer Center||Houston, Texas 77030|