Clofarabine in Combination With Cytarabine (Ara-C) and G-CSF Priming Followed by Infusion of Ex Vivo Expanded Cord Blood Progenitors for Patients With AML
I. Assess the safety of infusing off-the-shelf non-HLA matched expanded cord blood cells
following administration of cytarabine hydrochloride (GCLAC) for patients with AML.
I. Assess the ability of the product to provide temporary myeloid engraftment.
II. Assess the kinetics/persistence of potential engraftment.
III. Assess the kinetics of autologous recovery when compared to historical cohorts.
IV. Assess the development of alloimmunization.
INDUCTION THERAPY: Patients receive clofarabine intravenously (IV) over 1 hour and
cytarabine hydrochloride IV over 2 hours on days 1-5. Patients receive an infusion of
non-HLA matched ex vivo expanded cord blood progenitors on day 6. Filgrastim (G-CSF) is
administered subcutaneously (SC) on days 0-5 and from day 7 until blood counts recover.
Treatment modifications may apply according to response.
CONSOLIDATION THERAPY: Patients receive clofarabine IV over 1 hour and cytarabine
hydrochloride IV over 2 hours on days 1-5. Patients also receive G-CSF SC beginning on day 0
and continuing until blood counts recover.
Patients may receive treatment for 1-4 courses in the absence of disease progression or
After completion of study treatment, patients are followed up every 3-6 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
Grade 3 or greater infusion toxicity, as defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
Up to 24 hours after expanded progenitor cell infusion
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Food and Drug Administration
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