Leukemia, Myelogenous, Chronic, BCR-ABL Positive Clinical Trial
Official title:
Treatment of CML Patients With Imatinib and Hydroxyurea
The study will test the tolerability and efficacy of the combination therapy Imatinib/Hydroxyurea (HU) in patients with chronic myeloid leukemia (CML) in first chronic phase (CP1) newly diagnosted or failing interferon-based therapy.
The protocol consists of a part 1, a phase I study that will enrol 20 patients, with the
goal to determine the safety of the combination as well as the maximal tolerated dose. If
the toxicity of the combination is acceptable, up to 200 more patients may be recruited and
randomized to receive either Imatinib/HU or Imatinib alone (part 2).
Patients who meet the inclusion criteria will be started on 400 mg Imatinib daily. In part 1
of the protocol, the dose of HU will be increased by 500 mg at 3-weekly intervals until the
maximal tolerated dose has been reached. In part 2 of the study, patients will be randomized
to receive either the combination or Imatinib monotherapy.
Hematological and cytogenetic response will be evaluated at 3-months intervals during the
first year, and at 6 months' intervals thereafter. Primary endpoints for part 1 are
dose-limiting toxicity and maximal tolerated dose. Primary endpoints for part 2 are the
rates of major and complete molecular response at 6, 12 and 18 months, respectively.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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