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A randomized open-label study of 400 mg versus 800 mg of Gleevec/Glivec (imatinib mesylate) in patients with newly diagnosed, previously untreated chronic myeloid leukemia in chronic phase (CML-CP) us...

Update Il y a 4 ans
Reference: EUCTR2005-000657-29

A randomized open-label study of 400 mg versus 800 mg of Gleevec/Glivec (imatinib mesylate) in patients with newly diagnosed, previously untreated chronic myeloid leukemia in chronic phase (CML-CP) using molecular endpoints

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Extract

To establish whether 800 mg Gleevec/Glivec (as 400 mg bid) improves efficacy in newly diagnosed, previously untreated CML-CP patients as compared to 400 mg by the evaluation of the rate of molecular response defined as Bcr-Abl ratio ≤0.1% (≥ 3 log reductionof Bcr-Abl transcropts from a standardized baseline) as detected by RT-PCR at 12 months.

Inclusion criteria

  • Newly diagnosed Philadelphia chromosome (bcr-abl) positive (Ph+) chronic myeloid leukemia in chronic phase (CML-CP)

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