A Phase I Open-Label Study of High-Dose Cytarabine and Clofarabine in Adult Patients With Refractory or Relapsed Acute Myelogenous Leukemia or Refractory or Relapsed Acute Lymphoblastic Leukemia
- Determine the response rate in adult patients with relapsed or refractory acute myeloid
leukemia or acute lymphoblastic leukemia treated with high-dose cytarabine followed by
- Document the safety profile and tolerability of this regimen in these patients.
- Phase I: Patients receive high-dose cytarabine IV over 3 hours followed by clofarabine
IV over 2 hours on days 1-5. Treatment repeats for up to 4 courses (1-2 induction
courses, 2-3 post-remission courses) in the absence of disease progression or
A cohort of 3-6 patients receives the starting dose of clofarabine. If 1 of 6 patients
experiences dose-limiting toxicity (DLT), a subsequent cohort of patients receives
clofarabine at the next higher dose. If ≥ 2 of 6 patients experience DLT, the dose of
cytarabine is reduced and subsequent cohorts of patients receive cytarabine at reduced doses
and clofarabine as per the dose-escalation scheme above.
PROJECTED ACCRUAL: A total of 9 patients will be accrued for this study.
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Bayard L. Powell, MD
Comprehensive Cancer Center of Wake Forest University
United States: Federal Government
|Wake Forest University Comprehensive Cancer Center||Winston-Salem, North Carolina 27157-1096|