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

Last updated: August 9, 2007
Sponsor: University of Bologna
Overall Status: Completed

Phase

3

Condition

Chronic Myeloid Leukemia

Platelet Disorders

Leukemia

Treatment

N/A

Clinical Study ID

NCT00514488
ICSG/CML022
  • Ages > 18
  • All Genders

Study 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

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

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 uppernormal limits (UNL) and by creatinine > 20mg/L

  12. Any other disease or condition that by the advise of the responsible physician wouldmake the treatment dangerous for the patient or would make the patient ineligible forthe study, including physical, psychiatric, social and behavioural problems.

Study Design

Study Start date:
June 01, 2004
Estimated Completion Date:

Connect with a study center

  • Istituto di Ematologia e Oncologia Medica "L. e A. Seràgnoli"

    Bologna,
    Italy

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.