Clinical trial NCT00372619 (phase 1/phase 2, status: completed)
Conditions: leukemia
ICD codes: C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01
Drugs: clofarabine, cytarabine, methotrexate
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, CN(CC1=CN=C2N=C(N)N=C(N)C2=N1)C1=CC=C(C=C1)C(=O)N[C@@H](CCC(O)=O)C(O)=O
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed diagnosis of 1 of the following:

               -  Acute myeloid leukemia (AML) with ≥ 5% blasts in the bone marrow (M2/M3 bone
                  marrow) with or without extramedullary disease

               -  Acute lymphoblastic leukemia (ALL) with > 25% blasts in the bone marrow (M3 bone
                  marrow) with or without extramedullary disease

               -  Acute leukemia of ambiguous lineage with ≥ 5% blasts in the bone marrow (M2/M3
                  bone marrow) with or without extramedullary disease

          -  Disease must have relapsed after or be refractory to prior induction therapy

               -  Patients with AML or acute leukemia of ambiguous lineage must be in first relapse
                  OR refractory to first induction therapy with ≤ 1 attempt at remission induction

                    -  Patients with AML who enroll on the phase I portion of the study must have
                       received prior mitoxantrone hydrochloride and cytarabine for newly diagnosed
                       AML (phase I closed to accrual as of 09/16/09)

               -  Patients with ALL must be in second or third relapse (≤ 3 prior induction
                  regimens) OR refractory to reinduction in first relapse

                    -  Patients with ALL refractory to first induction therapy are not eligible

          -  No acute promyelocytic leukemia

          -  No CNS 3 involvement (i.e., WBC ≥ 5/μL in the cerebrospinal fluid with blasts present
             on cytospin)

        PATIENT CHARACTERISTICS:

          -  Karnofsky performance status (PS) 50-100% (> 16 years of age) OR Lansky PS 50-100% (≤
             16 years of age) OR ECOG PS 0-2

          -  Life expectancy ≥ 8 weeks

          -  Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min

          -  Direct bilirubin ≤ 1.5 times upper limit of normal (ULN)

          -  ALT < 2.5 times ULN (unless it is related to leukemic involvement)

          -  Shortening fraction ≥ 27% by echocardiogram OR ejection fraction ≥ 45% by gated
             radionuclide study

          -  No evidence of dyspnea at rest or exercise intolerance

          -  Pulse oximetry > 94% at room air

          -  Amylase ≤ 1.5 times ULN

          -  Lipase < 1.5 times ULN

          -  No active, uncontrolled grade 3 or 4 infection

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for ≥ 3 months after
             completion of study treatment

          -  No known hepatitis B or C infection or history of cirrhosis

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  Recovered from all prior therapy*

          -  At least 14 days since prior cytotoxic therapy (except hydroxyurea and intrathecal
             chemotherapy)*

          -  At least 7 days since prior biologic agent*

          -  At least 14 days since prior monoclonal antibody therapy*

          -  No more than 1 prior autologous or allogeneic hematopoietic stem cell transplantation

               -  No evidence of active graft-vs-host disease

               -  At least 4 months since transplantation

          -  No other concurrent chemotherapy or immunomodulating agents

          -  No other concurrent investigational therapy NOTE: *Patients who relapse during ALL
             maintenance therapy do not require a waiting period.