An Open Label Phase II Trial of Clofarabine and Temsirolimus in Older Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)
- To determine the complete response rate in older patients with relapsed or refractory
acute myeloid leukemia when treated with low-dose clofarabine and temsirolimus.
- To determine the tolerability and safety of this regimen.
- To determine the duration of response.
- To determine the duration of survival.
OUTLINE: This is a multicenter study.
- Induction therapy: Patients receive clofarabine IV over 1 hour on days 1-5 and
temsirolimus IV over 30 minutes on days 1, 8, and 15. Treatment continues for 1-2
courses in the absence of disease progression or unacceptable toxicity.
- Maintenance therapy: Patients achieving morphologic complete remission (CR) or CR with
incomplete blood count recovery receive temsirolimus IV over 30 minutes on days 1 and 8
of each month. Treatment continues for 12 months in the absence of disease progression
or unacceptable toxicity.
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Complete response rate
At 2 years from study entry
Sergio Amadori, MD
Ospedale Sant' Eugenio
Italy: Ethics Committee