A Phase II Study of Cloretazine® (VNP40101M) for Elderly Patients With De Novo Poor Risk Acute Myelogenous Leukemia
OBJECTIVES:
Primary
- Determine the complete response rate in older patients with poor-risk, de novo acute
myeloid leukemia treated with VNP40101M as induction therapy followed by cytarabine as
consolidation therapy.
Secondary
- Determine the probability of overall survival, leukemia-free survival, and
progression-free survival of patients treated with this regimen.
- Determine the safety of this regimen in these patients.
OUTLINE: This is an open-label, multicenter study.
- Induction therapy: Patients receive VNP40101M IV over 60 minutes on day 1 (course 1).
Patients without evidence of disease progression who have responding but residual
disease receive a second course of VNP40101M once between days 35-60. Patients
achieving complete response or partial response after induction therapy proceed to
consolidation therapy.
- Consolidation therapy: Beginning between days 45-90, patients receive cytarabine IV
continuously over 5 days (course 1). Patients may receive a second course of cytarabine
at the discretion of the investigator.
After completion of study treatment, patients are followed periodically for up to 36 months.
PROJECTED ACCRUAL: A total of 85 patients will be accrued for this study.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Complete response rate
No
Bonny L. Johnson, RN, MSN
Vion Pharmaceuticals
United States: Food and Drug Administration
CDR0000492755
NCT00354276
May 2006
Name | Location |
---|---|
Jonsson Comprehensive Cancer Center at UCLA | Los Angeles, California 90095-1781 |