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

Chronic Myeloid Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00219752
• Other study ID #: 020948
• Secondary ID: CSTI571AFR04
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: December 21, 2005
• Start date: May 2002
• Est. completion date: May 2007

Study information

• Verified date: September 2005
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Myeloid Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Intervention

Drug:
• Imatinib mesylate 400 mg

Locations

Country	Name	City	State
France	University Hospital	Poitiers

Sponsors (2)

Lead Sponsor	Collaborator
Poitiers University Hospital	Novartis

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tolerability
Primary	Quality of life
Secondary	. the survival without progression
Secondary	. the survival without event
Secondary	. the overall survival
Secondary	. the hematologic cytogenetic and molecular responses at various check points.
Secondary	. duration of responses and failure to respond

External Links

•   French CML Group (FI-LMC) web-site