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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:
ClinicalTrials.gov Identifier:
NCT00237120
First Posted: October 12, 2005
Last Update Posted: November 23, 2009
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.
Information provided by:
Novartis
  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
Intervention Model: Single Group Assignment
Masking: None (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
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   15 Years to 74 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): NCT00237120


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

Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00237120     History of Changes
Other Study ID Numbers: CSTI571AJP02
First Submitted: October 7, 2005
First Posted: October 12, 2005
Last Update Posted: November 23, 2009
Last Verified: November 2009

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 Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action