Clinical trial NCT00514488: Imatinib Standard Dose (400 mg/Day) Versus Imatinib High Dose (800 mg/Day)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Myeloid Leukemia
Keywords: chronic myeloid leukemia
STI 571
CML022
Lead sponsor: University of Bologna
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2007-08-10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Age \>/=18 years
2. First chronic phase, less than 6 months of duration
3. High Sokal's risk
4. Ph positive
5. No previous treatment or hydroxiurea only.
6. Performance status (ECOG/WHO) \< 2
7. Written informed consent

Exclusion Criteria:

1. Age \<18
2. Low or intermediate Sokal risk score.
3. More than 6 months from diagnosis.
4. Second chronic, accelerated or blastic phase
5. Scheduled allogeneic stem cell transplantation within 1 year from diagnosis.
6. Performance status (ECOG/WHO) \> 2
7. Inability to provide written informed consent
8. Pregnancy
9. Formal refusal of any recommendation of a safe contraception
10. Alcohol or drug addiction
11. Altered hepatic or renal function as defined by AST/ALT or bilirubine \> 3 times upper normal limits (UNL) and by creatinine \> 20mg/L
12. 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.

Primary outcomes:
measure: 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 outcomes:
measure: 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.
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto di Ematologia e Oncologia Medica "L. e A. Seràgnoli"
Study officials:
affiliation: Istituto di Ematologia e Oncologia Medica "L. e A. Seràgnoli" Università degli Studi di Bologna
name: Michele Baccarani, MD
role: PRINCIPAL_INVESTIGATOR
References:
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