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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00219752

Enrollment

Registered

2005-09-22

Start date

2002-05-31

Completion date

2007-05-31

Last updated

2005-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Myeloid Leukemia

Keywords

CML - ederly patients - Imatinib mesylate

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.

Interventions

DRUGImatinib mesylate 400 mg

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

70 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Tolerability	—
Quality of life	—

Secondary

Measure	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	—

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026