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Clinical Trial
. 2003 May;27(5):405-11.
doi: 10.1016/s0145-2126(02)00223-0.

A Randomized Study Comparing Interferon (IFN Alpha) Plus Low-Dose Cytarabine and Interferon Plus Hydroxyurea (HU) in Early Chronic-Phase Chronic Myeloid Leukemia (CML)

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Clinical Trial

A Randomized Study Comparing Interferon (IFN Alpha) Plus Low-Dose Cytarabine and Interferon Plus Hydroxyurea (HU) in Early Chronic-Phase Chronic Myeloid Leukemia (CML)

T Kühr et al. Leuk Res. .

Abstract

This multicenter randomized phase III study was designed to compare the efficacy and toxicity of IFN alpha-2c (3.5 MU/d) in combination with either araC (10 mg/m(2) d1-10) or hydroxyurea (HU: 25 mg/kg per day) in newly diagnosed CML patients. A total of 114 patients were randomized. Following a median observation period of 36 (range 1-73) months the major cytogenetic response rates were 25 and 27% and the 4-year survival probabilities 62.5 and 63% for the araC and HU group, respectively. While the overall toxicity profile was comparable between both groups, patients in the HU arm exhibited a slightly higher degree of WHO grades 3 and 4 non-hematological toxicities.

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