Status:
COMPLETED
A Study of Clofarabine in Older Patients With Acute Myeloid Leukemia (AML) for Whom Chemotherapy Is Not Suitable
Lead Sponsor:
Genzyme, a Sanofi Company
Collaborating Sponsors:
Bioenvision
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
65+ years
Phase:
PHASE2
Brief Summary
The purpose of the study is to determine if treatment of older patients indicated with untreated Acute Myeloid Leukemia (AML) who are not considered to be suitable for intensive chemotherapy, can effe...
Detailed Description
Note: This clinical trial was conducted by Bioenvision Ltd. Bioenvision Ltd. was acquired by Genzyme Corporation Oct 2007.
Eligibility Criteria
Inclusion
- Provide signed, written informed consent
- Have untreated AML according to World Health Organization (WHO) classification
- Male or post-menopausal female ≥ 65 years of age
- Unsuitable for intensive chemotherapy
- Be able to comply with study procedures and follow-up examination
- Male patient who are fertile agree to use and effective barrier method of birth control to avoid pregnancies
- Have adequate liver and renal function as indicated by certain laboratory values
Exclusion
- Received previous treatment with clofarabine
- Are receiving other chemotherapy or corticosteroids (low-dose corticosteroid for pre-medication purposes are allowed)
- Have received prior treatment for leukemia. Growth factor, cytokine support, leukopheresis or hydroxyurea will be allowed but must be discontinued at least 24 hours prior to start of treatment with clofarabine
- Have a psychiatric disorder that would interfere with consent, study participation, or follow-up
- Have an active, uncontrolled systemic infection
- Are currently participating in other investigational drug studies or having received other investigational drugs within the previous 30 days
- Have symptomatic central nervous system (CNS) involvement
- Blast transformation of chronic myeloid leukemia or acute promyelocytic leukemia
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT00924443
Start Date
June 1 2004
End Date
March 1 2008
Last Update
April 1 2015
Active Locations (15)
Enter a location and click search to find clinical trials sorted by distance.
1
Dublin, Ireland
2
Bologna, Italy
3
Rome, Italy
4
Belfast, Northern Ireland, United Kingdom