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

Chronic Myeloid Leukemia Clinical Trial

— CML022  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00514488
• Other study ID #: ICSG/CML022
• Status: Completed
• Phase: Phase 3
• First received: August 9, 2007
• Last updated: August 9, 2007
• Start date: June 2004

Study information

• Verified date: July 2007
• Source: University of Bologna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines AgencyItaly: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Chronic Myeloid Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid

Intervention

Drug:
• STI571 (400 mg/day; or 800 mg/day)

Locations

Country	Name	City	State
Italy	Istituto di Ematologia e Oncologia Medica "L. e A. Seràgnoli"	Bologna

Sponsors (2)

Lead Sponsor	Collaborator
University of Bologna	Novartis

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.