Leukemia, Chronic Myeloid Clinical Trial
Official title:
Evaluation of the Therapeutic Effect of Hydroxyurea Pulse Therapy for Chronic Myeloid Leukemia Patients
RATIONALE: Drugs used in chronic-phase chronic myelogenous leukemia (CML) aimed to avoid CML
conversion (AP, BC). Hydroxyurea pulse therapy for chronic-phase CML patients is effective
based on the investigator's previous studies, and the scheme cost lower than imatinib. It is
not yet known the efficacy compared Hydroxyurea pulse therapy with imatinib for chronic-phase
CML, especially to achieve hematological remission in short time.
PURPOSE: Non-randomized trial to compare the effectiveness of hydroxyurea pulse therapy with
that of imatinib in treating chronic-phase CML patients.
OBJECTIVES: I. Compare the time of WBC decreased by 10%,20%,30%,50% of these patients treated
with these two drugs. II. Compare the time of spleen size decreased by 10%,20%,30%,50% of
chronic-phase chronic myelogenous leukemia patients treated with imatinib to those treated
with hydroxyurea pulse therapy. III. Compare the time to achieve complete remission (CR) of
these patients treated with these two drugs. iv. Estimate the overall survival, event-free
survival, progression-free survival (OS, EFS, PFS) and major cytogenetic response of these
patients treated with these two drugs.
OUTLINE: Patients are to receive one of two treatments. Arm I: Induction: Patients receive
oral hydroxyurea daily (hydroxyurea pulse therapy) until hematological remission.
Maintenance: continuing hydroxyurea pulse therapy to maintain white blood cells below 8. 0 ×
109 / L. Arm II: Induction: Patients receive imatinib 400mg qd until acceptable blood counts
are achieved. Maintenance: Follow the recommendations of the NCCN guidelines for
chronic-phase CML treatment.
PROJECTED ACCRUAL: A total of 60 patients (30 per arm) will be accrued for this study within
2 years.
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