A Phase II 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
OUTLINE: This is an open-label phase II study. Patients are stratified according to
diagnosis (acute myeloid leukemia vs acute lymphoblastic leukemia Phase II: Patients receive
high-dose cytarabine followed by clofarabine (at the dose determined in phase I) on days
After completion of study treatment, patients are followed periodically for up to 5 years.
PROJECTED ACCRUAL: A total of 39 patients were accrued for this study.
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Measure Patient Response to High-dose Cytarabine Followed by Clofarabine in Adult Patients With Relapsed or Refractory AML
Response to the therapy is measured by a defined improvement in Neutrophil and platlet counts, along with improved cellularity of bone marrow biopsy (>20% with maturation of all cell lines), <5% blasts, auer rods must not be detectable and extramedullary leukemia or soft tissue involvment must not be present.
Bayard L. Powell, MD
Comprehensive Cancer Center of Wake Forest University
United States: Institutional Review Board
21204 Phase 2
|Wake Forest University Comprehensive Cancer Center||Winston-Salem, North Carolina 27157-1096|