Clinical trial NCT02349178 (phase 2, status: terminated)
Conditions: leukemia, acute lymphoblastic, acute myeloid leukemia
ICD codes: C91.01, C91.02, C91.00, C92.A1, C92.A2, C92.61, C92.62, C92.A0, C92.60
Drugs: clofarabine, cyclophosphamide, etoposide
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, OCCOCCN1CCN(CC1)C(C1=CC=CC=C1)C1=CC=C(Cl)C=C1
Reason stopped: 
    low accrual
  
Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of acute lymphoblastic leukemia (ALL) or acute myeloid leukemia (AML) with <
             5% blasts in the bone marrow (M1) by morphology and that meets one of the following
             criteria:

        Flow cytometric evidence of MRD (≥ 0.01% leukemic blasts for ALL or ≥ 0.5% leukemic blasts
        for AML detected in the bone marrow) OR Molecular/cytogenetic evidence of disease (FISH or
        PCR methodology) performed within 7 days And with the intent of going on to an allogeneic
        hematopoietic cell transplantation (HCT) independent of this study

          -  Patients must have an available donor and have intention of proceeding directly to
             ALL-HCT after completion of 1 cycle of Bridging therapy.

          -  Age 0 to 39 years

          -  Karnofsky Performance Status ≥ 50% for patients 16 years and older and Lansky Play
             Score ≥ 50 for patients under 16 years of age (see Appendix 2)

          -  Patients must have a life expectancy ≥ 8 weeks as determined by the enrolling
             investigator

          -  Have acceptable organ function as defined within 7 days of study registration

        Renal: creatinine clearance ≥ 60 mL/min/1.73 m2 or serum creatinine based on age/gender as
        follows:

        Hepatic: ALT < 5 x upper limit of normal (ULN) and total bilirubin ≤ 1.5 x upper limit of
        normal (ULN) for age Cardiac: left ventricular ejection fraction ≥ 40% by ECHO/MUGA

          -  Patients must have fully recovered from the acute toxic effects of all prior
             chemotherapy, immunotherapy, or radiotherapy prior to entering this study. At least 7
             days must have elapsed from prior chemotherapy.

          -  Hematopoietic Growth Factors: At least 7 days since the completion of therapy with a
             growth factor and at least 14 days since pegfilgrastim (Neulasta®) administration.

          -  Sexually active females of child bearing potential must agree to use adequate
             contraception (diaphragm, birth control pills, injections, intrauterine device [IUD],
             surgical sterilization, subcutaneous implants, or abstinence, etc.) for the duration
             of treatment and for 2 months after the last dose of chemotherapy. Sexually active men
             must agree to use barrier contraceptive for the duration of treatment and for 2 months
             after the last dose of chemotherapy.

          -  Voluntary written consent before performance of any study-related procedure not part
             of normal medical care, with the understanding that consent may be withdrawn by the
             subject at any time without prejudice to future medical care.

        Exclusion Criteria:

          -  Acute Promyelocytic Leukemia (APL)

          -  Active extramedullary disease (CNS ≥ CNS2 and/or testicular leukemia) or presence of
             chloromatous disease

          -  Receiving concomitant chemotherapy, radiation therapy; immunotherapy or other
             anti-cancer therapy other than is specified in the protocol

          -  Systemic fungal, bacterial, viral, or other infection not controlled (defined as
             exhibiting ongoing signs/symptoms related to the infection and without improvement,
             despite appropriate antibiotics or other treatment)

          -  Pregnant or lactating. The agents used in this study are known to be teratogenic to a
             fetus and there is no information on the excretion of agents into breast milk. All
             females of childbearing potential must have a blood test or urine study within 2 weeks
             prior to registration to rule out pregnancy.

          -  Known allergy to any of the agents or their ingredients used in this study

          -  Participating in a concomitant Phase 1 or 2 study