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

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by:
University of Bologna
ClinicalTrials.gov Identifier:
NCT00514488
First received: August 9, 2007
Last updated: NA
Last verified: July 2007
History: No changes posted

August 9, 2007
August 9, 2007
June 2004
Not Provided
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.
Same as current
No Changes Posted
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.
Same as current
Not Provided
Not Provided
 
Imatinib Standard Dose (400 mg/Day) Versus Imatinib High Dose (800 mg/Day)
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

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Chronic Myeloid Leukemia
Drug: STI571 (400 mg/day; or 800 mg/day)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
Not Provided
Not Provided

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00514488
ICSG/CML022
No
Not Provided
University of Bologna
Novartis
Principal Investigator: Michele Baccarani, MD Istituto di Ematologia e Oncologia Medica "L. e A. Seràgnoli" Università degli Studi di Bologna
University of Bologna
July 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP