Leukemia Clinical Trial
Official title:
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
RATIONALE: Drugs used in chemotherapy, such as cytarabine and clofarabine, work in different
ways to stop the growth of cancer cells, either by killing the cells or by stopping them
from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer
cells.
PURPOSE: This phase II trial is studying clofarabine when given together with cytarabine to
see how well they work in treating patients with refractory or relapsed acute myeloid
leukemia or acute lymphoblastic leukemia.
OBJECTIVES:
- 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
clofarabine.
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
1-3.
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.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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