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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
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Bologna:

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.

Study Start Date: June 2004
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00514488

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

No publications provided by University of Bologna

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00514488     History of Changes
Other Study ID Numbers: ICSG/CML022
Study First Received: August 9, 2007
Last Updated: August 9, 2007
Health Authority: Italy: The Italian Medicines Agency
Italy: Ethics Committee

Keywords provided by University of Bologna:
chronic myeloid leukemia
STI 571
CML022

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
 Imatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013