Clofarabine and Daunorubicin in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia
Condition: Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Intervention: clofarabine; daunorubicin hydrochloride; cytogenetic analysis; protein expression analysis; immunologic technique; pharmacological study
Intervention description: IV; IV; Correlative study; Correlative Study; Correlative Study; Correlative Study
Intervention MeSH terms: Daunorubicin; Clofarabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 60 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: adult erythroleukemia (M6a); adult pure erythroid leukemia (M6b); adult acute megakaryoblastic leukemia (M7); adult acute minimally differentiated myeloid leukemia (M0); adult acute monoblastic leukemia (M5a); adult acute monocytic leukemia (M5b); adult acute myeloblastic leukemia with maturation (M2); adult acute myeloblastic leukemia without maturation (M1); adult acute myelomonocytic leukemia (M4); untreated adult acute myeloid leukemia; adult acute myeloid leukemia with 11q23 (MLL) abnormalities; adult acute myeloid leukemia with inv(16)(p13;q22); adult acute myeloid leukemia with t(16;16)(p13;q22); adult acute myeloid leukemia with t(8;21)(q22;q22); secondary acute myeloid leukemia

Summary:

      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.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Newly diagnosed acute myeloid leukemia

               -  At least 10% blasts in the peripheral blood

          -  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

               -  Nonmelanoma skin cancer, in situ carcinoma, or cervical intraepithelial
                  neoplasia, regardless of the disease-free duration, are allowed 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 values are also eligible
                  for this study if hormonal therapy has been initiated or a radical prostatectomy
                  has been performed

          -  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

               -  Prior hydroxyurea allowed