Acute Myeloid Leukemia Clinical Trial
Official title:
A Phase II Study of Clofarabine and Cytarabine for Patients With Newly Diagnosed Acute Myeloid Leukemia Who Have Persistent Disease After Treatment With an Anthracycline and Cytarabine
The combination of clofarabine and cytarabine is an effective and reasonably well-tolerated treatment regimen in patients with either relapsed/refractory or newly diagnosed AML. For this prospective study, we propose the use of clofarabine and cytarabine for second course induction therapy for patients with persistent AML after treatment with an anthracycline and cytarabine.
The primary objective of this prospective study is to evaluate the efficacy (i.e., complete
response rate) of clofarabine and cytarabine as second course therapy for the treatment of
AML. The secondary objectives are to assess the treatment-related toxicities, to determine
the overall and relapse-free survival for patients with AML who are treated with this
regimen, and to evaluate potential factors that are predictive of response.
The investigational nature and objective of this study, the procedures involved and their
associated risks, potential benefits, and potential alternative therapies will be explained
to the patient, and a signed informed consent document will be obtained. Once consented,
eligible patients will be treated by the acute leukemia service on the University of
Pittsburgh Cancer Institute inpatient unit.
Prior to the start of chemotherapy, patients will receive dexamethasone and ondansetron as
pre-medication. Clofarabine will then be administered as intravenous infusion on days 1
through 5. Patients will be monitored closely with vital signs. Cytarabine will then be
given as intravenous infusion, starting 3 (maximum of 4) hours after the completion of
clofarabine administration on days 1 through 5.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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