Imatinib Standard Dose (400 mg/Day) Versus Imatinib High Dose (800 mg/Day)

Study Overview
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Brief Summary
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This is a phase III multicenter, open-label study designed to investigate the efficacy (hematological response, cytogenetic response and molecular response) and feasibility (tolerance, compliance and safety) of the tyrosine kinase inhibitor imatinib mesylate (formerly STI 571, GLIVEC, Novartis Pharma) at conventional dose (400 mg/daily) if compared with high dose (800 mg/daily) (serial number protocol ICSG/CML/022) in patients with Ph+ chronic myeloid leukemia (CML) in chronic phase (CP) previously untreated, at high Sokal risk.

Official Title
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A Phase III Study Comparing Imatinib Standard Dose (400 mg/Day) Versus Imatinib High Dose (800 mg/Day) in the Treatment of Newly Diagnosed High Risk Chronic Myeloid Leukemia in Chronic Phase

Conditions
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Chronic Myeloid Leukemia

Intervention / Treatment
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* Drug: STI571 (400 mg/day; or 800 mg/day)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >/=18 years First chronic phase, less than 6 months of duration High Sokal's risk Ph positive No previous treatment or hydroxiurea only. Performance status (ECOG/WHO) < 2 Written informed consent Exclusion Criteria: Age <18 Low or intermediate Sokal risk score. More than 6 months from diagnosis. Second chronic, accelerated or blastic phase Scheduled allogeneic stem cell transplantation within 1 year from diagnosis. Performance status (ECOG/WHO) > 2 Inability to provide written informed consent Pregnancy Formal refusal of any recommendation of a safe contraception Alcohol or drug addiction Altered hepatic or renal function as defined by AST/ALT or bilirubine > 3 times upper normal limits (UNL) and by creatinine > 20mg/L Any other disease or condition that by the advise of the responsible physician would make the treatment dangerous for the patient or would make the patient ineligible for the study, including physical, psychiatric, social and behavioural problems.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: STI571 (400 mg/day; or 800 mg/day)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the rate of complete cytogenetic response at 12 months in adult patients with previously untreated high Sokal risk CML treated with imatinib at 2 different dose levels of 400 and 800 mg/daily. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of major cytogenetic response,the kinetic and duration of cytogenetic response, the time to accelerated and blast crisis and overall survival,safety and tolerability of the treatment. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic myeloid leukemia, STI 571, CML022