Clofarabine, Idarubicin, and Cytarabine Combination in Acute Myeloid Leukemia (AML) Induction
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Intervention: Clofarabine; Idarubicin; Cytarabine
Intervention description: Induction Cycle: 20 mg/m^2 IV over approximately 1 hour daily for 5 days (days 1-5); Induction Cycle: 10 mg/m^2 IV over approximately 30 minutes daily for 3 days (days 1-3), following clofarabine by 1 to 2 hours; Induction Cycle: 1 g/m^2 IV over approximately 2 hours daily for 5 days (days 1-5), follow clofarabine by 3 to 6 hours.
Intervention MeSH terms: Cytarabine; Clofarabine; Idarubicin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Leukemia; AML; chemotherapy-naïve; Clofarabine; Clofarex; Clolar; Idarubicin; Idamycin; Cytarabine; Ara-C; Cytosar; DepoCyt; Cytosine Arabinosine Hydrochloride

Summary:

      The goal of this clinical research study is to learn if the combination of clofarabine,
      cytarabine, and idarubicin can help to control Acute Myeloid Leukemia (AML) in patients who
      are between the ages of 18 and 60 years old. The safety of this study drug combination will
      also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosis of AML (World Health Organization (WHO) classification)

          2. Patients must be chemotherapy-naïve, i.e. not have received any prior cytotoxic
             chemotherapy for AML (with the exception of hydroxyurea). They could have received
             prior therapy with hypomethylating agents, targeted, or biological agents.

          3. Age 18 to 60 years.

          4. Eastern Cooperative Oncology Group (ECOG) performance status </= 2.

          5. 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/1.73m^2 as calculated by the
             Modification of Diet in Renal Disease equation where Predicted GFR
             (ml/min/1.73m^2)=186 * (serum creatinine)^-1.154 x (age in years)^-0.023 * (0.742 if
             patient is female) * (1.212 if patient is black), where SCr is serum creatinine
             measured in mg/dL. serum bilirubin </= 1.5 * upper limit of normal (ULN) (unless
             increase is due to hemolysis or a congenital disorder); serum transaminases (SGPT
             and/or SGOT) </= 2.5 * ULN.

          6. Cardiac ejection fraction >/= 45% (by either echocardiography or MUGA scan).

          7. Ability to understand and provide signed informed consent.

        Exclusion Criteria:

          1. Patients with acute promyelocytic leukemia (APL).

          2. Any coexisting medical condition that in the judgment of the treating physician is
             likely to interfere with study procedures or results.

          3. Nursing women, women of childbearing potential with positive urine pregnancy test, or
             women of childbearing potential who are not willing to maintain adequate contraception
             (such as birth control pills, intrauterine device (IUD), diaphragm, abstinence, or
             condoms by their partner) over the entire course of therapy.

          4. Active and uncontrolled infection requiring therapy with IV antibiotics or antifungal
             therapy. Prior or concurrent history of one or more opportunistic infections (e.g.,
             cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria
             other than TB).