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

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by:
Poitiers University Hospital
ClinicalTrials.gov Identifier:
NCT00219752
First received: September 13, 2005
Last updated: December 21, 2005
Last verified: September 2005
History of Changes
  Purpose

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 Intervention Phase
Chronic Myeloid Leukemia
 Drug: Imatinib mesylate 400 mg
 Phase 2

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: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Poitiers University Hospital:

Primary Outcome Measures:
  • Tolerability
  • Quality of life

Secondary Outcome Measures:
  • . 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

Estimated Enrollment: 30
Study Start Date: May 2002
Estimated Study Completion Date: May 2007
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.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00219752

Locations
France
University Hospital
Poitiers, France, 86021
Sponsors and Collaborators
Poitiers University Hospital
Novartis
Investigators
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)
  More Information

Additional Information:
French CML Group (FI-LMC) web-site  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00219752     History of Changes
Other Study ID Numbers: 020948, CSTI571AFR04
Study First Received: September 13, 2005
Last Updated: December 21, 2005
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

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 17, 2013