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

This study has been completed.
Information provided by:
ClinicalTrials.gov Identifier:
First received: October 7, 2005
Last updated: November 20, 2009
Last verified: November 2009
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:

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

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Study Chair: Novartis Novartis
  More Information

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

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

ClinicalTrials.gov processed this record on May 04, 2016