A Study of Clofarabine in Older Patients With Acute Myeloid Leukemia (AML) for Whom Chemotherapy Is Not Suitable

A Phase II Trial of Clofarabine in Older Patients With Acute Myeloid Leukemia for Whom Intensive Chemotherapy is Not Considered Suitable

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 effectively be treated with Clofarabine.

Note: This clinical trial was conducted by Bioenvision Ltd. Bioenvision Ltd. was acquired by Genzyme Corporation Oct 2007.

Inclusion Criteria:

• 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 Criteria:

• 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