Clofarabine, Cytarabine, and Filgrastim in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia, Advanced Myelodysplastic Syndrome, and/or Advanced Myeloproliferative Neoplasm
Condition: Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Del(5q); Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(15;17)(q22;q12); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Chronic Myelomonocytic Leukemia; de Novo Myelodysplastic Syndromes; Refractory Anemia With Excess Blasts; Untreated Adult Acute Myeloid Leukemia; Myeloproliferative Neoplasm With 10% Blasts or Higher
MeSH terms: Leukemia; Neoplasms; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Preleukemia; Leukemia, Myelomonocytic, Chronic; Leukemia, Myelomonocytic, Juvenile; Myelodysplastic Syndromes; Myeloproliferative Disorders; Anemia, Refractory; Anemia, Refractory, with Excess of Blasts; Syndrome
Intervention: filgrastim; clofarabine; cytarabine
Intervention description: Given SC; Given IV; Given IV
Intervention MeSH terms: Cytarabine; Clofarabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No

Summary:

      This phase II trial is studying how well giving clofarabine and cytarabine together with
      filgrastim works in treating patients with newly diagnosed acute myeloid leukemia (AML),
      advanced myelodysplastic syndrome (MDS), and/or advanced myeloproliferative neoplasm. Drugs
      used in chemotherapy, such as clofarabine and cytarabine, work in different ways to stop the
      growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving
      the drugs in different doses may kill more cancer cells. Colony stimulating factors, such as
      filgrastim, may increase the number of immune cells found in bone marrow or peripheral blood
      and may help the immune system recover from the side effects of chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of acute myeloid leukemia by World Health Organization (WHO) criteria
             (except acute promyelocytic leukemia), or myelodysplastic syndrome, RAEB-2 by WHO
             classification or advanced myeloproliferative neoplasm with >= 10% blasts in the bone
             marrow or peripheral blood, including chronic myelomonocytic leukemia (CMML)-2 by WHO
             classification

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status 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/1.73 m^2 as calculated by the
             Modification of Diet in Renal Disease equation

          -  Serum bilirubin =< 1.5 x upper limit of normal (ULN) unless elevation is thought to be
             due to Gilbert's syndrome, hemolysis, or hepatic infiltration by the hematologic
             malignancy

          -  Aspartate transferase (AST)/alanine transferase (ALT) =< 2.5 x ULN unless elevation is
             thought to be due to hepatic infiltration by the hematologic malignancy

          -  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 90 days after study treatment

        Exclusion Criteria:

          -  Current concomitant chemotherapy, radiation therapy, or immunotherapy other than as
             specified in the protocol with the exception of intrathecal chemotherapy administered
             on days that are not concurrent with clofarabine and cytarabine

          -  No prior induction chemotherapy for AML; treatment with hydroxyurea is permitted;
             treatment with imides or hypomethylating agents for preceding hematological disorders
             is permitted

          -  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 significant organ compromise due to systemic fungal, bacterial, viral,
             or other infection

          -  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