Polyethylene Glycol Interferon Alfa-2b (PEG Intron) Versus Interferon Alfa-2b (INTRON^® A) in the Treatment of Newly Diagnosed Chronic Myelogenous Leukemia (CML) (C98026)

A RANDOMIZED PHASE 2/3 TRIAL OF SCH 54031 PEG12000 INTERFERON ALFA-2b (PEG INTRON, SCH 54031) VS. INTRON A (SCH 30500) IN SUBJECTS WITH NEWLY DIAGNOSED CML (PROTOCOL NOS. C/I98-026)

The primary purpose of this study is to compare the efficacy of polyethylene glycol (PEG; pegylated) interferon alfa-2b (PEG Intron, C98026) versus interferon alfa-2b (Intron® A) in the treatment of participants with newly diagnosed CML.

Inclusion Criteria

• Has chronic phase CML diagnosed within 3 months prior to study enrollment

• Has chronic phase CML positive for Ph^1 as confirmed by cytogenetic studies, performed by a central laboratory

• Has platelet count >/= 50,000/microl

• Has hemoglobin >/= 9.0 g/dL

• Has WBC count >/=2000/microl but </= 50,000/microl

• Has adequate hepatic and renal function, as defined by the following parameters obtained within 14 days prior to initiation of study treatment

  • serum glutamic oxaloacetic transaminase (SGOT) <2 times upper limit of laboratory normal (ULN)
  • serum glutamic pyruvic transaminase SGPT <2 times upper ULN
  • serum bilirubin <2 times ULN
  • serum creatinine <2.0 mg/dL

• Is fully recovered from any prior major surgery and must be at least 4 weeks postoperative

• Has Eastern Cooperative Oncology Group Performance Status of 0-2

• Has signed a written, voluntary informed consent before study entry, is willing to participate in this study, and is willing to complete all follow-up assessments

Exclusion Criteria:

• Has accelerated phase CML as defined by any of the following criteria.

  • peripheral blood myeloblasts >/=15%
  • peripheral blood basophils >/= 20%
  • peripheral blood myeloblasts plus promyelocytes >/=30%
  • platelets <100,000/microl, unrelated to therapy

• Has blastic phase CML (30% myeloblasts in peripheral blood or bone marrow)

• Is a candidate for and is planning to receive allogeneic, syngeneic, or autologous bone marrow transplantation within the next 12 months

• Has received prior treatment for their CML, except for hydroxyurea (collection of stem cells without using high dose chemotherapy for mobilization is acceptable)

• Has severe cardiovascular disease (i. e., arrhythmias requiring chronic treatment, congestive heart failure [New York Heart Association (NYHA) Class III or IV], or symptomatic ischemic heart disease)

• Has a history of a neuropsychiatric disorder requiring hospitalization

• Has thyroid dysfunction not responsive to therapy

• Has uncontrolled diabetes mellitus

• Has a history of seropositivity for human immunodeficiency virus

• Has active and/or uncontrolled infection, including active hepatitis

• Has a medical condition requiring chronic systemic corticosteroids

• Has a history of prior malignancies within the last 5 years, except for surgically cured non-melanoma skin cancer, or cervical carcinoma in situ

• Has received any experimental therapy within 30 days prior to enrollment in this study

• Is known to be actively abusing alcohol or drugs

• Is pregnant, nursing, or of reproductive potential and is not practicing an effective means of contraception