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
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
RATIONALE: Drugs used in chemotherapy, such as clofarabine and daunorubicin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving clofarabine together with daunorubicin may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving clofarabine together with daunorubicin works in treating older patients with newly diagnosed acute myeloid leukemia.
OBJECTIVES:
Primary
Secondary
OUTLINE:
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.
DISEASE CHARACTERISTICS:
Newly diagnosed acute myeloid leukemia
De novo or secondary disease
No acute promyelocytic leukemia with t[15;17] or any other variant
No clinical evidence of CNS disease
PATIENT CHARACTERISTICS:
ECOG performance status 0-2
Serum bilirubin ≤ 1.5 times upper limit of normal (ULN)
AST and ALT ≤ 2.5 times ULN
Alkaline phosphatase ≤ 2.5 times ULN
LVEF ≥ 45%
Estimated glomerular filtration rate ≥ 50 mL/min
Not pregnant or nursing
Fertile patients must use effective barrier contraception during and for at least 6 months following study treatment
No known HIV positivity
Able to comply with study procedures and follow-up examinations
No psychiatric disorders that would interfere with consent, study participation, or follow-up
No uncontrolled systemic fungal, bacterial, viral, or other infection (i.e., exhibiting ongoing signs/symptoms related to the infection and without improvement despite appropriate antibiotics or other treatment)
No history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system that may place the patient at undue risk to undergo induction therapy with both agents
No other malignancy, unless disease-free for at least 3 years following curative intent therapy
No other severe concurrent disease
PRIOR CONCURRENT THERAPY:
No other concurrent systemic antileukemic therapy (standard or investigational)
No concurrent cytotoxic therapy or investigational therapy
No concurrent alternative medications (e.g., herbal or botanical for anticancer purposes)
No prior chemotherapy