Leukemia Clinical Trial
Official title:
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
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 I trial is studying the side effects and best dose of clofarabine when
given together with cytarabine and 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.
- 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
unacceptable toxicity.
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.
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