Imatinib Standard Dose (400 mg/Day) Versus Imatinib High Dose (800 mg/Day)
Information source: University of Bologna
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Myeloid Leukemia
Intervention: STI571 (400 mg/day; or 800 mg/day) (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: University of Bologna Official(s) and/or principal investigator(s):
Michele Baccarani, MD, Principal Investigator, Affiliation: Istituto di Ematologia e Oncologia Medica "L. e A. Seràgnoli" Università degli Studi di Bologna
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.
Clinical Details
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 design: Randomized, Open Label, Dose Comparison, Parallel Assignment
Primary outcome: 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: 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Istituto di Ematologia e Oncologia Medica "L. e A. Seràgnoli", Bologna, Italy
Additional Information
Starting date: June 2004
Last updated: August 9, 2007
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