A Phase II Study Evaluating Mechanisms of Resistance Following Treatment With Clofarabine and Daunorubicin in Newly Diagnosed Adult Acute Myeloid Leukemia Patients > or = to 60 Years Old
- Study complete response (CR) and CR without platelet recovery (CRp) following treatment
with clofarabine and daunorubicin hydrochloride in older patients with newly diagnosed
acute myeloid leukemia.
- Study disease-free and overall survival of these patients following treatment with this
- Compare disease-free and overall survival of patients whose cells do or do not
demonstrate apoptosis following treatment with this regimen.
- Induction therapy: Patients receive clofarabine IV over 1 hour on days 1-5 and
daunorubicin hydrochloride IV over 5 minutes on days 1, 3, and 5. Patients are assessed
after induction course 1. Patients with ≥ 5% blasts in bone marrow may receive another
course of induction therapy beginning between 28-84 days after initiation of course 1.
Patients who achieve complete remission (CR) or CR without platelet recovery (CRp)
(after 1 or 2 courses of induction therapy) proceed to consolidation therapy.
- Consolidation therapy: Beginning between 28 -84 days after initiation of last course of
induction therapy, patients receive clofarabine IV over 1 hour on days 1-3 and
daunorubicin hydrochloride IV over 5 minutes on days 1 and 3. Patients may receive a
second course of consolidation therapy beginning between 28-84 days of consolidation
Blood and bone marrow samples are collected periodically to assess response and for
pharmacokinetic, cytogenetic, immunophenotyping, and molecular analyses.
After completion of study treatment, patients are followed for at least 2 years.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Complete remission (CR) or complete remission in the absence of total platelet recovery (CRp)
Meir Wetzler, MD
Roswell Park Cancer Institute
United States: Institutional Review Board
|Roswell Park Cancer Institute||Buffalo, New York 14263|