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

Poitiers University Hospital1 site in 1 country30 target enrollmentMay 2002

ConditionsChronic Myeloid Leukemia

DrugsImatinib mesylate 400 mg

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Chronic Myeloid Leukemia
Sponsor: Poitiers University Hospital
Enrollment: 30
Locations: 1
Primary Endpoint: Quality of life
Status: Completed
Last Updated: 20 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 2002

End Date

May 2007

Last Updated

20 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Poitiers University Hospital

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