The purpose of this study is to determine if PEG-Intron is better tolerated and more
efficacious than standard interferons (Roferon, Intron) in patients with
Philadelphia-positive Chronic Myelogenous Leukemia. These patients should have previously
received standard interferon therapy and have been intolerant, resistant, or have relapsed
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
- 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.
- 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
- 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.