CML022: Imatinib Standard Dose (400 mg/Day) Versus Imatinib High Dose (800 mg/Day)

Sponsor

University of Bologna (Other)

Overall Status

Completed

CT.gov ID

NCT00514488

Collaborator

Novartis (Industry)

Location

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Myeloid Leukemia	Drug: STI571 (400 mg/day; or 800 mg/day)	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

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 Start Date :

Jun 1, 2004

Outcome Measures

Primary Outcome Measures

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

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 Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.