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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Chronic Myeloid Leukemia

Intervention / Treatment
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* Drug: Imatinib mesylate 400 mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Imatinib mesylate 400 mg|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability |  |  | 
| Quality of life |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| . 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CML - ederly patients - Imatinib mesylate