Dose Escalation Study of Clofarabine in Combination With Cytarabine (Ara-C) and G-CSF Priming for Relapsed or Refractory Acute Myeloid Leukemia (AML) Patients
I. To determine the maximum tolerated dose of clofarabine, and the dose-limiting toxicities
of the combination of clofarabine and cytarabine with G-CSF priming, in the treatment of
patients with relapsed or refractory AML.
I. To determine the hematological and non-hematological side effect profile of the
combination of clofarabine, cytarabine, and G-CSF.
II. To determine the efficacy of clofarabine in combination with cytarabine and G-CSF
priming in the treatment of patients with relapsed or refractory AML.
III. To determine the disease-free and overall survival after therapy with clofarabine,
cytarabine, and G-CSF for relapsed or refractory AML.
OUTLINE: This is a dose escalation study of clofarabine.
INDUCTION THERAPY: Patients receive clofarabine IV over 1 hour and cytarabine IV over 2
hours on days 1-5, and filgrastim (G-CSF) subcutaneously once daily beginning 24 hours prior
to chemotherapy and continuing until blood count recover. Patients with residual leukemia
(>= 5% blasts by morphology) at day 14 and if blast remain > 5% by day 21 receive a second
course of induction therapy.
CONSOLIDATION THERAPY: Patients receive clofarabine, cytarabine, and G-CSF as in induction
therapy. Patients may receive a second course of consolidation therapy depending on response
and whether additional therapy (e.g., stem cell transplant or donor lymphocyte infusion) is
PARTS II and III:
Patients receive induction therapy and consolidation therapy as in part 1.
After completion of study treatment, patients are followed every 3 months for 2 years and
then annually for 3 years.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose of clofarabine
45 days after the last dose of clofarabine
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Institutional Review Board
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Seattle, Washington 98109|