Phase II Clofarabine and Cytarabine for Newly Diagnosed Acute Myeloid Leukemia
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Intervention: Clofarabine; Cytarabine
Intervention description: Clofarabine will be administered as a 1-hour (range: 1 hour minimum to 2 hours maximum) intravenous infusion at a dose of 40mg/m2 daily on days 1 through 5.; Cytarabine at a dose of 1g/m2 daily will be given as a 2-hour intravenous infusion, starting 3 hours after the completion of clofarabine administration on days 1 through 5.
Intervention MeSH terms: Cytarabine; Clofarabine; Antimetabolites
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: AML; clofarabine; cytarabine; persistent AML; induction therapy

Summary:

      The combination of clofarabine and cytarabine is an effective and reasonably well-tolerated
      treatment regimen in patients with either relapsed/refractory or newly diagnosed AML. For
      this prospective study, we propose the use of clofarabine and cytarabine for second course
      induction therapy for patients with persistent AML after treatment with an anthracycline and
      cytarabine.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with newly diagnosed AML based on the World Health Organization
             classification who have persistent disease after their first course treatment with an
             anthracycline and cytarabine

          2. Able to understand and have the ability to provide written informed consent

          3. Patients over 18 years of age

          4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

          5. Left ventricular ejection fraction (LVEF) ≥ 50%

          6. Negative urine pregnancy test for all females

          7. All subjects must agree to use an effective method of contraception while receiving
             the study drugs

        Exclusion Criteria:

          1. Diagnosis of acute promyelocytic leukemia

          2. Relapsed AML

          3. Prior use of clofarabine

          4. Previous allogeneic or autologous hematopoietic cell transplantation

          5. Impaired liver function (serum total bilirubin > 2.0 mg/dL, alanine aminotransferase
             and aspartate aminotransferase ≥ 4 x the upper limit of normal)

          6. Impaired renal function (serum creatinine ≥ 2.0 mg/dL)

          7. Uncontrolled or life-threatening infection that is not responding to antimicrobial
             therapy

          8. History of a psychiatric disorder which may compromise compliance with the protocol or
             which does not allow for appropriate informed consent

          9. Concurrent active malignancy; exceptions include patients who have been disease free
             for 5 years, patients with a history of completely resected non-melanoma skin cancer
             or successfully treated in situ carcinoma, or patients with another malignancy that is
             indolent or definitively treated

         10. Evidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated
             respiratory or cardiac disease)