PEG-Intron For Chronic Myelogenous Leukemia Patients Unresponsive To Or Intolerant Of Roferon Or Intron

Inclusion Criteria:

• Chronic phase CML, documented by the presence of Philadelphia chromosome or bcr/abl rearrangement at time of diagnosis, confirmed by either cytogenetics or PCR.
• WBC >/= 3000/ul </=100,000/ul.
• Patients must have received prior interferon therapy & proven to have primary refractory disease, secondary resistance or intolerance to interferon-a
• Patient must have ECOG status of 0, 1, or 2
• Labs: SGOT/SGPT<2xULN; serum bilirubin<2xULN; serum creatinine <2.0mg/dl
• Recovered from effects of major surgery
• Life expectancy > 12 wks.
• Signed informed consent.
• Women of childbearing potential must have negative serum pregnancy test within 72 hrs prior to administration of PEG-Intron & use effective contraception during the study.

Exclusion Criteria:

• NO accelerated Phase CML patients with peripheral blood: blasts>/=15%, basophils>/=20%, blasts+promyelocytes>/=30%, platelets<100,000/ul (unrelated to therapy). Blastic phase CML:>/=30% in peripheral blood/bone marrow.
• NO patients with known hypersensitivity to interferon-a.
• NO severe cardiovascular disease, i.e. arrhythmias requiring chronic treatment or congestive heart failure (NYHA classification III/IV).
• NO history of neuropsychiatric disorder requiring hospitalization.
• NO patients requiring therapy for refractory thyroid dysfunction
• NO patients with uncontrolled diabetes mellitus.
• NO patients who have had treatment for a 2nd malignancy in the past 5 yrs, except for localized basal cell/squamous cell carcinoma of the skin or cervical carcinoma in situ.
• NO pregnant or lactating patients.
• NO patients known to be actively using alcohol or drugs
• NO patients receiving any experimental therapy within 30 days of enrollment in study.