Back to resultsSafety and Efficacy of Imatinib in Chronic Myelogenous Patients Older Than 70 Years
Primary Purpose
Chronic Myeloid Leukemia
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Imatinib mesylate 400 mg
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Myeloid Leukemia focused on measuring CML - ederly patients - Imatinib mesylate
Eligibility 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
Sites / Locations
- University Hospital
Outcomes
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
Full Information
NCT ID
NCT00219752
First Posted
September 13, 2005
Last Updated
December 21, 2005
Sponsor
Poitiers University Hospital
Collaborators
Novartis
1. Study Identification
Unique Protocol Identification Number
NCT00219752
Brief Title
Safety and Efficacy of Imatinib in Chronic Myelogenous Patients Older Than 70 Years
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 Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
May 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2007 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Poitiers University Hospital
Collaborators
Novartis
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Myeloid Leukemia
Keywords
CML - ederly patients - Imatinib mesylate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Imatinib mesylate 400 mg
Primary Outcome Measure Information:
Title
Tolerability
Title
Quality of life
Secondary Outcome Measure Information:
Title
. the survival without progression
Title
. the survival without event
Title
. the overall survival
Title
. the hematologic cytogenetic and molecular responses at various check points.
Title
. duration of responses and failure to respond
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François GUILHOT, MD
Organizational Affiliation
Department of Oncology hematology and Cell therapy, University Hospital , 86021 Poitiers - FRANCE
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Philippe ROUSSELOT, MD
Organizational Affiliation
Department of Hematology and Oncology - University Hospital "Saint Louis" - 75475 PARIS cedex 10 (FRANCE)
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Poitiers
ZIP/Postal Code
86021
Country
France
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of Imatinib in Chronic Myelogenous Patients Older Than 70 Years
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