Clinical trial NCT02057770 (phase 1, status: terminated)
Conditions: leukemia, myeloid, acute
ICD codes: C92.A1, C92.A2, C92.61, C92.62, C92.A0, C92.60
Drugs: busulfan, fludarabine phosphate, cyclophosphamide, tocilizumab
SMILES: CS(=O)(=O)OCCCCOS(C)(=O)=O, NC1=NC(F)=NC2=C1N=CN2[C@@H]1O[C@H](CO)[C@@H](O)[C@@H]1O, ClCCN(CCCl)P1(=O)NCCCO1
Reason stopped: 
    low accrual rate
  
Eligibility criteria:

        Inclusion Criteria:

          -  AML without complete remission (CR/CRc/CRi) after at least 2 induction therapies OR

          -  AML that has relapsed within 6 months after obtaining a CR OR

          -  AML that has relapsed more than 6 months after obtaining a CR, and has treatment
             failure (TF) or progressive disease (PD) following at least 1 re-induction regimen OR

          -  AML that has relapsed post Allogeneic transplantation

          -  Active AML (bone marrow blasts ≥ 5% by morphology, staining, or flow) and/or presence
             of estramedullary disease

          -  Available HLA-haploidentical donor that meets the following criteria:

               -  Blood-related family member (sibling (full or half), offspring, or parent,
                  cousin, niece or nephew, aunt or uncle, or grandparent)

               -  At least 18 years of age

               -  HLA-haploidentical donor/recipient match by at least low-resolution typing per
                  institutional standards

               -  In the investigator's opinion, is in general good health, and medically able to
                  tolerate leukapheresis required for harvesting HSC

               -  No active hepatitis

               -  Negative for HTLV and HIV

               -  Not pregnant

        NOTE: there were HLA-matched sibling and HLA-matched unrelated donor cohorts, but those
        closed without completion of accrual with Amendment 11

          -  Karnofsky performance status ≥ 50 %

          -  Adequate organ function as defined below:

               -  Total bilirubin ≤ 2.5 mg/dl (unless the patient has a history of Gilbert's
                  syndrome)

               -  AST(SGOT) and ALT(SGPT) ≤ 3.0 x IULN

               -  Creatinine ≤ 2.0 x IULN OR estimated creatinine clearance ≥ 30 mL/min/1.73 m2 by
                  Cockcroft-Gault Formula

               -  Oxygen saturation ≥ 90% on room air

               -  LVEF ≥ 40%

               -  FEV1 and FVC ≥ 40% predicted, DLCOc ≥ 40% predicted. If DLCO is < 40%, patients
                  will still be considered eligible if deemed safe after a pulmonary evaluation.

          -  At least 18 years of age at the time of study registration

          -  Able to understand and willing to sign an IRB approved written informed consent
             document (or that of legally authorized representative, if applicable)

        Exclusion Criteria:

          -  Circulating blast count ≥ 10,000/uL by morphology or flow cytometry (cytoreductive
             therapies including leukapheresis or hydroxyurea are allowed)

          -  Known HIV or Active hepatitis B or C infection

          -  Known hypersensitivity to one or more of the study agents

          -  Currently receiving or has received any investigational drugs within the 14 days prior
             to the first dose of study drug (Day -7)

          -  Currently receiving or has received any intensive chemotherapy within the 14 days
             prior to the first dose of study drug (Day -7) (hydrea or other non-intensive regimens
             such as decitabine may be used but must stop at least one day prior to the first dose
             of study drug)

          -  Pregnant and/or breastfeeding

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, unstable
             cardiac arrhythmias, or psychiatric illness/social situations that would limit
             compliance with study requirements.