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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00219752
• Date of registration: 13/09/2005
• Prospective Registration: No
• Primary sponsor: Poitiers University Hospital
• Public title: Safety and Efficacy of Imatinib in Chronic Myelogenous Patients Older Than 70 Years
• Scientific 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
• Date of first enrolment: May 2002
• Target sample size: 30
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00219752
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

France

Contacts

• Name: François GUILHOT, MD
• Affiliation: Department of Oncology hematology and Cell therapy, University Hospital , 86021 Poitiers - FRANCE

• Name: Philippe ROUSSELOT, MD
• Affiliation: Department of Hematology and Oncology - University Hospital "Saint Louis" - 75475 PARIS cedex 10 (FRANCE)

Key inclusion & exclusion 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



Age minimum: 70 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Chronic Myeloid Leukemia

Intervention(s)

Drug: Imatinib mesylate 400 mg

Primary Outcome(s)

Quality of life

Tolerability

Secondary Outcome(s)

. the overall survival

. the hematologic cytogenetic and molecular responses at various check points.

. duration of responses and failure to respond

. the survival without event

. the survival without progression

Secondary ID(s)

CSTI571AFR04

020948

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Novartis