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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-05-31

Study Completion Date

2007-05-31

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.

Conditions

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Chronic Myeloid Leukemia

Keywords

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CML - ederly patients - Imatinib mesylate

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Imatinib mesylate 400 mg

Intervention Type DRUG

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

Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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François GUILHOT, MD

Role: STUDY_CHAIR

Department of Oncology hematology and Cell therapy, University Hospital , 86021 Poitiers - FRANCE

Philippe ROUSSELOT, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Hematology and Oncology - University Hospital "Saint Louis" - 75475 PARIS cedex 10 (FRANCE)

Locations

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University Hospital

Poitiers, , France

Site Status

Countries

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France

Other Identifiers

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CSTI571AFR04

Identifier Type: -

Identifier Source: secondary_id

020948