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
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To assess the complete remission (CR) rate of this regimen as compared with 7 + 3 standard
      induction with the 90 mg/m^2/dose of daunorubicin (historical control) in previously
      untreated patients with AML or advanced MDS or advanced myeloproliferative neoplasm less than
      age 65.

      SECONDARY OBJECTIVES:

      I. To determine the event free survival (EFS), overall survival (OS) and treatment related
      mortality of this regimen.

      II. To assess the toxicity of this regimen in previously untreated patients. III. To
      determine whether 3 consolidation chemotherapy cycles consisting of G-CSF (filgrastim),
      clofarabine, and cytarabine (GCLAC) can be administered with prompt recovery of blood counts.

      OUTLINE:

      INDUCTION THERAPY: Patients receive filgrastim subcutaneously (SC) daily beginning the day
      prior to chemotherapy and continuing until blood counts recover. Patients receive clofarabine
      intravenously (IV) over 1 hour followed by cytarabine IV over 2 hours daily for 5 days.

      CONSOLIDATION THERAPY: Patients receive filgrastim SC daily for 5 days beginning the day
      prior to chemotherapy. Patients receive clofarabine IV over 1 hour followed by cytarabine IV
      over 2 hours daily for 4 days.

      Treatment with induction therapy may continue for up to 2 courses and treatment with
      consolidation therapy may continue for up to 3 courses in the absence of disease progression
      or unacceptable toxicity.

      After completion of study treatment, patients are followed up every 3 months for 2 years and
      then annually for 5 years.
    

Intervention name(s): filgrastim; clofarabine; cytarabine
Intervention type(s): Biological; Drug; Drug
Intervention description(s): Given SC; Given IV; Given IV
Other intervention name(s): G-CSF; Neupogen; CAFdA; Clofarex; Clolar; ARA-C; arabinofuranosylcytosine; arabinosylcytosine; Cytosar-U; cytosine arabinoside
Intervention MeSH terms: Cytarabine; Clofarabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment