Leukemia Clinical Trial
Official title:
A Phase II Trial of Cytarabine and Clofarabine in Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL)
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 how well giving cytarabine together with
clofarabine works in treating patients with relapsed or refractory acute lymphoblastic
leukemia.
Primary objective:
- Determine whether the complete remission rate in adult patients with relapsed or
refractory acute lymphoblastic leukemia (ALL) is sufficiently high after treatment with
cytarabine and clofarabine to warrant further investigation.
Secondary objectives:
- Estimate the frequency and severity of toxicities associated with this dosing schedule
of cytarabine and clofarabine.
- Investigate, preliminarily, the prognostic effects of cytogenetic features on response
to treatment in these patients.
Other objectives (if funding allows):
- Investigate, preliminarily, the prognostic effects of laboratory correlates (expression
of nucleoside transporters, expression of other pertinent genes by tissue microarray)
and FISH features on response to treatment in these patients
OUTLINE: This is an open-label, multicenter study.
- Induction therapy (1 or 2 courses): Patients receive induction therapy comprising
clofarabine IV over 1 hour followed 4 hours later by cytarabine IV over 2 hours on days
1-5 (course 1). Patients who achieve a response (5-25% blasts in the bone marrow with a
≥ 50% reduction in blasts from initial bone marrow aspirate) receive 1 more course of
induction therapy beginning no later than day 45. Patients who achieve complete
remission (< 5% blasts in the bone marrow) after 1 or 2 courses of induction therapy
may proceed to consolidation therapy.
- Consolidation therapy (1 course): Beginning within 60 days after the first day of the
last induction therapy, patients may receive consolidation therapy comprising
clofarabine IV over 1 hour followed 4 hours later by cytarabine IV over 2 hours on days
1-4.
After completion of study treatment, patients are followed periodically for up to 5 years.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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