Safety and Efficacy of Imatinib in Chronic Myelogenous Patients Older Than 70 Years

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: NCT00219752
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : December 22, 2005
Information provided by:
Poitiers University Hospital

Brief Summary:
The aim of this phase II trial is asses the tolerability and the effectiveness of imatinib in patients with chronic myelogenous leukemia in chronic phase with age more than 70, diagnosis of cml is being performed within 1 year. Quality of life will be carefully assessed.

Condition or disease Intervention/treatment Phase
Chronic Myeloid Leukemia Drug: Imatinib mesylate 400 mg Phase 2

Detailed Description:

Patients will received Imatinib at a dose of 400mg daily. Tolerability and quality of life will be assessed Secondary objectives are : to evaluate the survival without progression, the survival without event, the overall survival, the hematologic, cytogenetic and molecular responses at various check points.

Duration of responses and failure to respond will be evaluated.

Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial to Study the Tolerability and the Effectiveness of Imatinib in Patients With Chronic Myelogenous Leukemia in Chronic Phase With Age More Than 70, Diagnosis of CML is Being Performed Within 1 Year
Study Start Date : May 2002
Study Completion Date : May 2007

Primary Outcome Measures :
  1. Tolerability
  2. Quality of life

Secondary Outcome Measures :
  1. . the survival without progression
  2. . the survival without event
  3. . the overall survival
  4. . the hematologic cytogenetic and molecular responses at various check points.
  5. . duration of responses and failure to respond

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Ages Eligible for Study:   70 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • CML Ph+ (assessed by cytogenetic or FISH)
  • Chronic phase with less than 5% bone marrow blasts
  • Diagnosis within 12 months
  • Age ≥ 70 year at inclusion
  • PS grade 0 to 2 (ECOG)
  • Mini mental status more than 25
  • Hydroxyurea optional before Imatinib
  • Adequate end organ function, defined as the following: total bilirubin <1.5x uln, sgpt <3x uln, creatinine <1.5x uln.

Exclusion Criteria:

  • patients who cannot sign an informed consent indicating that they are aware of the investigational nature of this study in keeping with the policies of the hospital
  • Mini mental status ≤ 25
  • patients who are not able to adequately take the study drug
  • Age less than 70 y
  • accelerated or blastic phase
  • previous therapy with imatinib or interferon
  • HIV positivity

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): NCT00219752

University Hospital
Poitiers, France, 86021
Sponsors and Collaborators
Poitiers University Hospital
Study Chair: François GUILHOT, MD Department of Oncology hematology and Cell therapy, University Hospital , 86021 Poitiers - FRANCE
Principal Investigator: Philippe ROUSSELOT, MD Department of Hematology and Oncology - University Hospital "Saint Louis" - 75475 PARIS cedex 10 (FRANCE)

Additional Information: Identifier: NCT00219752     History of Changes
Other Study ID Numbers: 020948
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: December 22, 2005
Last Verified: September 2005

Keywords provided by Poitiers University Hospital:
CML - ederly patients - Imatinib mesylate

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