Clinical trial NCT01193400 (phase 2, status: terminated)
Conditions: acute myelogenous leukemia
ICD codes: C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01
Drugs: clofarabine, cytarabine
SMILES: [H][C@@]12C[C@@H](C)[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])CCC2=CC(=O)C=C[C@]12C, ClCCN(CCCl)P1(=O)NCCCO1
Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosis of AML (de novo, secondary, or hematological disorder), according to WHO
             criteria.

          2. Older than or equal to 60 years

          3. ECOG performance status 0-2

          4. At least one of the following factors:

               -  Older than or equal to 70 years

               -  Prior hematological disorder (AHD)

               -  ECOG performance status 2

               -  Unfavorable karyotype (ie, adverse) defined as any cytogenetic profile except the
                  presence of any of the following:

                  t(8;21)(q22;q22) inv(16)(p13q22) or t(16;16)(p13;q22) t(15;17)(q22;q12) and
                  variants

          5. Provide written informed consent form.

          6. Being able to comply with study procedures and follow-up evaluations.

          7. Not to be fertile or willing to use a method of birth control during the study until
             the end of the last visit of the treatment.

          8. Adequate renal and hepatic function as follows:

               -  Total bilirubin <= 1,5 x upper of institutional normal limit (ULN) and

               -  AST y ALT <=2,5 x ULN and

               -  Serum creatinine <=1,0 mg/dL of serum creatinine <01,0 mg/dL, then, glomerular
                  filtration rate (GFR) estimated must be >60 mL/min/1,73 m2 calculated from the
                  equation of the Modification of Diet in Renal Disease (MDRD).

          9. Adequate cardiac function determined by at least one of the following:

               -  Left ventricular ejection fraction (LVEF) >=40% measured by echocardiography in
                  Multiple Gated Acquisition (MUGA) scan or isotope angiography or

               -  Left ventricular fractional shortening >=22% measured by echocardiography.

        Exclusion Criteria:

          1. Diagnosis of acute promyelocytic leukaemia (APL) in French-American-British
             classification M3º or attending to the WHO classification t(15;17)(q22;q12), (PML/RAR
             and variants).

          2. Pre-treatment with clofarabine.

          3. Previous treatment for AML or a hematological disorder AHD (excluding palliative care,
             hydroxyurea, hematopoietic cytokines or lenalidomide [the latter only for a specific
             AHD]). Hematopoietic cytokines and lenalidomide should not have been administered
             within the 14 days preceding the first dose of study drug. If it is received any
             previous treatment for AML or AHD within the time limits allowed, drug-related
             toxicity, must have recovered to Grade 1 or less before the first dose of study drug.

          4. Previous hematopoietic stem cell transplantation (HSCT).

          5. External beam pelvic radiotherapy.

          6. Have received an investigational product within 30 days before the first dose of study
             drug. If the patient has received any investigational product before this time, the
             drug-related toxicity, must have recovered to Grade 1 or less before the first dose of
             study drug.

          7. Inadequate renal and hepatic function as follows:

               -  Total bilirubin >1,5 x institutional upper limit normal (ULN) provided it is not
                  attributable to the very LMA or

               -  AST y ALT >2,5 x ULN provided it is not attributable to the very LMA or

               -  Serum creatinine >1,0 mg/dL provided that the glomerular filtration rate (GFR)
                  estimated to be ≤60 mL/min/1,73 m2 calculated by the equation of the Modification
                  of Diet in Renal Disease (MDRD).

          8. Inadequate cardiac function determined by at least one of the following:

               -  Left ventricular ejection fraction <40% measured by echocardiography in Multiple
                  Gated Acquisition (MUGA) or isotope angiography; or

               -  Left ventricular fractional shortening <22% measured by echocardiography.

          9. Poor general condition ECOG 3-4.

         10. Refusal to sign informed consent form.

         11. Inability to comply with study visits and inspections.

         12. Psychiatric disorders that could interfere with the consent, participation or
             monitoring of the study.

         13. Fungal Systemic disease, bacterial, viral or other uncontrolled infection (defined as
             manifestation of signs / symptoms related to ongoing infection and without
             improvement, although receiving adequate antibiotic therapy or other treatment).

         14. Any other concomitant serious disease or a history of severe organ dysfunction or
             heart, kidney, liver or other organ system which may involve the patient in excessive
             risk when exposed to clofarabine.

         15. Diagnosis of another malignancy neoplasia, unless the patient has been disease-free
             for at least five years after completing an attempt curative therapy with the
             following exceptions:

               -  Patients with non-melanoma skin cancer, carcinoma in situ or cervical
                  intraepithelial neoplasia, irrespective of the duration of disease-free period,
                  are eligible for the study if it has finalized a definitive treatment for the
                  disease.

               -  Patients with prostate cancer confined to the organ without evidence of recurrent
                  or progressive disease based on figures for the prostate specific antigen (PSA)
                  are also candidates for the study if hormonal therapy has been initiated or has
                  made a radical prostatectomy.

         16. Clinical evidence which may indicate central nervous system (CNS) leukemia unless
             lumbar puncture to confirm the absence of leukemic blasts in the cerebrospinal fluid
             (CSF).

         17. Previous positive test for human immunodeficiency virus (HIV).