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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00514488
Recruitment Status : Completed
First Posted : August 10, 2007
Last Update Posted : August 10, 2007
Information provided by:
University of Bologna

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

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Study Type : Interventional  (Clinical Trial)
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 : June 2004

Primary Outcome Measures :
  1. 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 :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00514488

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Istituto di Ematologia e Oncologia Medica "L. e A. Seràgnoli"
Bologna, Italy
Sponsors and Collaborators
University of Bologna
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Principal Investigator: Michele Baccarani, MD Istituto di Ematologia e Oncologia Medica "L. e A. Seràgnoli" Università degli Studi di Bologna

Publications automatically indexed to this study by Identifier (NCT Number):

Layout table for additonal information Identifier: NCT00514488    
Other Study ID Numbers: ICSG/CML022
First Posted: August 10, 2007    Key Record Dates
Last Update Posted: August 10, 2007
Last Verified: July 2007
Keywords provided by University of Bologna:
chronic myeloid leukemia
STI 571
Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action