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

Poitiers University Hospital

Status and phase

Completed

Phase 2

Conditions

Chronic Myeloid Leukemia

Treatments

Drug: Imatinib mesylate 400 mg

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00219752

CSTI571AFR04

020948

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

70+ years old

Volunteers

No Healthy Volunteers

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