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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
344
Weekly SC injection of pegylated interferon alfa-2b, 6.0 microg/kg
Daily SC injection of interferon alfa-2b, 5 MIU/m\^2
Number of Participants With Cytogenetic Responses to PEG Intron and INTRON A at 12 Months
Cytogenetic response (CR) was defined by the degree of suppression of Philadelphia chromosome (Ph\^1) achieved during study treatment. For all participants continuing treatment after study conclusion, cytogenetic assessments were conducted locally as per standard of care. Determination of CR at 12 months were based on cytogenetic analysis of bone marrow aspirate samples. The CR criteria were based on the percentage (%) of PH\^1-positive cells during study treatment. Protocol-defined CR criteria were Complete Response (0%), Partial Response (1-34%), Minor Response (35-90%), or No Response (\>90%). Data for the analysis population was based on the intent-to-treat principle. Participants who were treatment failures at 6 months were considered cytogenetic non-responders. Recording of CR was independent of hematologic responses.
Time frame: Up to 12 months
Number of Participants With Cytogenetic Response (CR) to PEG Intron and Intron A at 6 Months
Cytogenetic response (CR) at 6 months, as at 12 months, was defined by the degree of suppression of Philadelphia chromosome (Ph\^1) achieved during study treatment. The determination of CR at 6 months was based on cytogenetic analysis of bone marrow aspirate samples. The CR criteria were based on the percentage (%) of PH\^1-positive cells during study treatment. Protocol-defined CR criteria were Complete (0%), Partial (1-34%), Minor (35-90%), or No Response (\>90%). Data for the analysis population was based on the intent-to-treat principle. Participants who were treatment failures at 6 months were considered cytogenetic non-responders. Recording of CR was independent of hematologic responses.
Time frame: 6 months
Number of Participants With Hematologic Responses to PEG Intron and Intron A at 6 Months
Hematologic response at 6 months was assessed, while the hematologic response was measured at 3, 6, 9 and 12 months during the first year of study treatment. To be considered a hematologic responder a participant must have met all of the following criteria for a minimum of 28 days: WBC count \<10,000/μL; platelet count \<450,000/L; normal differential count in peripheral blood (manual differential count); no palpable spleen. Participants achieving a complete hematologic response at 3 months had the cytogenetic response evaluated at 3 months as well. Participants who achieved a complete hematologic response by 6 months continued treatment for another 6 months. Participants who failed to achieve a complete hematologic response after 6 months of treatment were considered treatment failures, and further treatment for this group was at the discretion of the treating physician. Participants may have continued to receive their assigned study medication for an additional 6 months.
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Time frame: 6 months
Number of Participants With Overall Survival
Participants were followed for survival; those who did not achieve a major cytogenetic response were discontinued from the study. For participants who completed 1 year of study treatment and continued to Year 2 and beyond, survival and disease progression every 3 months were assessed, and serious adverse events (SAEs) were reported. Participants were followed until resolution of any drug-related nonserious adverse event, and any SAE occurring while on the study or within 30 days of last dose of study drug. Participant death during survival follow-up was reported to the drug safety unit of the Sponsor. Each participant (whether discontinued or still on treatment) was followed every 3 months for survival and disease progression information. Overall survival was analyzed using the log-rank statistic, and the hazard ratio (HR) and 95% confidence interval (CI) for the HR were obtained using Cox's proportional hazards model.
Time frame: Up to 2 years (24 months), and beyond