A Phase II Trial of Clofarabine and Cytarabine to Treat Minimal Residual Disease (MRD) in Acute Myeloid Leukemia
Inclusion Criteria:
- Diagnosis of AML by World Health Organization (WHO) criteria
- Persistence of MRD by flow cytometry (phenotypic blast population detectable at >=
0.1% by flow cytometry despite < 5% blasts by morphology) after initial induction and
one to four cycles of cytarabine containing consolidation chemotherapy
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
- Serum creatinine =< 1.0 mg/dL; if serum creatinine > 1.0 mg/dL, then the estimated
glomerular filtration rate (GFR) must be > 60 mL/min/1.73m^2 as calculated by the
Modification of Diet in Renal Disease equation, as reported by University of
Washington Medical Center (UWMC) laboratory system
- Serum bilirubin =< 1.5 x upper limit of normal (ULN)
- Aspartate transaminase (AST)/alanine transaminase (ALT) =< 2.5 x ULN
- Alkaline phosphatase =< 2.5 x ULN
- Capable of understanding the investigational nature, potential risks and benefits of
the study, and able to provide valid informed consent
- Female patients of childbearing potential must have a negative serum pregnancy test
within 2 weeks prior to enrollment
- Male and female patients must use an effective contraceptive method during the study
and for a minimum of 6 months after study treatment
Exclusion Criteria:
- Current concomitant chemotherapy, radiation therapy, or immunotherapy other than as
specified in the protocol
- Use of investigational agents within 30 days or any anticancer therapy within 2 weeks
before study entry, with exceptions for oral agents such as FMS-like tyrosine kinase
3 (Flt3) Inhibitors or hydroxyurea which will be discontinued prior to the
investigational drug regimen; intrathecal treatment within two weeks will also be
allowed but not permitted to be given concurrently with investigational regimen
- The patient must have recovered from all acute non-hematological toxicities from any
previous therapy
- Have any other severe concurrent disease, or have a 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 treatment
- Patients with a systemic fungal, bacterial, viral, or other infection not controlled
(defined as exhibiting ongoing signs/symptoms related to the infection and without
improvement, despite appropriate antibiotics or other treatment)
- Pregnant or lactating patients
- Any significant concurrent illness, condition, or psychiatric disorder that would
compromise patient safety or compliance, interfere with consent, study participation,
follow up, or interpretation of study results
- Have had a diagnosis of another malignancy, unless the patient has been disease free
for at least 3 years following the completion of curative intent therapy including
the following:
- Patients with treated non-melanoma skin cancer, in situ carcinoma, or cervical
intraepithelial neoplasia, regardless of the disease-free duration, are eligible for
this study if definitive treatment for the condition has been completed
- Patients with organ-confined prostate cancer with no evidence of recurrent or
progressive disease based on prostate-specific antigen (PSA) values are also eligible
for this study if hormonal therapy has been initiated or a radical prostatectomy has
been performed
- Prior allogeneic stem cell transplant
- Prior treatment with clofarabine