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Efficacy, Safety and Long-term Prognosis of Imatinib in Patients Newly Diagnosed With Chronic Myelogenous Leukemia (Chronic Phase)

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00237120
First received: October 7, 2005
Last updated: November 20, 2009
Last verified: November 2009
History of Changes
  Purpose

This study will assess the safety and efficacy of imatinib in newly enrolled previously untreated patients with chronic phase CML.


Condition Intervention Phase
Chronic Myelogenous Leukemia in Chronic Phase
 Drug: Imatinib
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy, Safety and Long-term Prognosis of Imatinib in Patients Newly Diagnosed With Chronic Myelogenous Leukemia (Chronic Phase)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • 3 years overall survival
  • Duration of remaining in chronic phase

Secondary Outcome Measures:
  • Cytogenetic response and hematologyc response in every 3 or 6 months with 3 years treatment of Imatinib,
  • Adverse event

Estimated Enrollment: 100
Study Start Date: November 2002
Study Completion Date: June 2007
  Eligibility

Ages Eligible for Study:   15 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed as Chronic Myelogenous Leukemia in Chronic Phase
  • Previously untreated with Interferon-alpha
  • Performance status is normal or capable of only limited self-care

Exclusion Criteria:

  • Patients who are pregnant or possibly pregnant
  • Significant hepatic diseases
  • Chronic Myelogenous Leukemia in advanced phase

Other protocol-defined inclusion/exclusion criteria may apply.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00237120

Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Novartis
  More Information

No publications provided

Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00237120     History of Changes
Other Study ID Numbers: CSTI571AJP02
Study First Received: October 7, 2005
Last Updated: November 20, 2009
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Novartis:
Chronic Myelogenous Leukemia
Imatinib
CML

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 June 18, 2013