Status:
COMPLETED
Safety and Efficacy of Imatinib in Chronic Myelogenous Patients Older Than 70 Years
Lead Sponsor:
Poitiers University Hospital
Collaborating Sponsors:
Novartis
Conditions:
Chronic Myeloid Leukemia
Eligibility:
All Genders
70+ years
Phase:
PHASE2
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 bei...
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 withou...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2002
Trial Type :
INTERVENTIONAL
End Date :
May 1 2007
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00219752
Start Date
May 1 2002
End Date
May 1 2007
Last Update
December 22 2005
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University Hospital
Poitiers, France, 86021