A Study of Clofarabine for Older Patients With Newly Diagnosed Acute Myelogenous Leukemia (AML) (CLASSIC II)
Condition: Acute Myelogenous Leukemia; Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Intervention: clofarabine
Intervention description: Induction cycle 1: cycle 1 of clofarabine 30 mg/m^2/day as a 1-hour intravenous infusion for 5 consecutive days.
Reinduction (cycle 2) and/or Consolidation cycles (cycles 2-6): cycles repeated minimally every 28 days, of clofarabine 20 mg/m^2/day as a 1-hour intravenous infusion for 5 consecutive days.
Intervention MeSH terms: Clofarabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 116.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No
Keywords: Acute myelogenous leukemia; Acute myeloid leukemia; newly Diagnosed AML; Clofarabine; CLASSIC II; CLO243

Summary:

      Clolar (clofarabine injection) is approved by the Food and Drug Administration (FDA) for the
      treatment of pediatric patients 1 to 21 years old with relapsed acute lymphoblastic leukemia
      (ALL) who have had at least 2 prior treatment regimens.

      This study will evaluate the efficacy of clofarabine in elderly patients with acute
      myelogenous leukemia (AML) who are unlikely to benefit from treatment with intensive
      chemotherapy regimens (cytarabine and anthracycline based regimens) used in younger patients
      with AML.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of AML (de novo, secondary or with an antecedent hematologic disorder [AHD])

          -  Age ≥ 60 years

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2

          -  Presence of at least one adverse prognostic factor: Age ≥ 70 years; or AHD; or ECOG
             performance status of 2; or Intermediate or unfavorable (i.e., adverse) karyotype
             defined as any cytogenetic profile except the presence of any of the following:

               -  t(8;21)(q22;q22)

               -  inv(16)(p13;q22 or t(16;16)(p13;q22)

               -  t(15;17)(q22;q12) and variants.

          -  Adequate renal and hepatic function: Total bilirubin ≤ 1.5 x upper limit of normal
             (ULN); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x
             ULN; and 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 (MDRD) equation

          -  Adequate cardiac function: left ventricular ejection fraction (LVEF) ≥ 40% or left
             ventricular fractional shortening ≥ 22%

        Exclusion Criteria:

          -  Diagnosis of acute promyelocytic leukemia

          -  Prior treatment with clofarabine

          -  Prior treatment for AML or an antecedent hematologic disorder

          -  Prior hematopoietic stem cell transplant (HSCT)

          -  Prior radiation therapy to the pelvis

          -  Investigational agent received within 30 days prior to the first dose of study drug

          -  Ongoing uncontrolled systemic infection

          -  Diagnosis of another malignancy, unless the patient has been disease-free for at least
             5 years following the completion of curative intent therapy with the following
             exceptions: Patients with treated non-melanoma skin cancer, in-situ carcinoma or
             cervical intraepithelial neoplasia regardless of 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 PSA value are eligible for this study if hormonal therapy has been
             initiated or a radical prostatectomy has been performed

          -  Clinical evidence of central nervous system (CNS) involvement

          -  Severe concurrent medical condition or psychiatric disorder that would preclude study
             participation

          -  Positive human immunodeficiency virus (HIV) test