Pilot Study Evaluating the Use of Ex Vivo Expanded Cord Blood Progenitors as Supportive Care Following Induction Chemotherapy (FLAG) in Patients With Relapsed/Refractory AML

Inclusion Criteria:

- Patients must have a diagnosis of AML according to World Health Organization (WHO)
classification with >= 5% of disease in bone marrow (BM), with or without
extramedullary disease or biopsy-proven isolated myeloid sarcoma (myeloblastoma,
chloroma, including leukemia cutis) in the absence of marrow involvement

- AML:

- If relapse AML:

- Must have a prior diagnosis of AML and be in 1st or greater relapse

- Must not have received prior reinduction therapy for this relapse

- If primary refractory AML:

- Must have had a prior diagnosis of AML and

- Must not have received more than 3 previous induction attempts

- Patients must be classified as central nervous system (CNS)1 or CNS 2 and
without clinical signs of CNS leukemia such as cranial nerve palsy; patients
with CNS 3 disease are not eligible

- Must have a Lansky or Karnofsky performance status of >= 50; use Karnofsky for
patients > 16 years of age and Lansky for patients =< 16 years of age

- Patients must have recovered from the acute toxicity of all prior chemotherapy;
patients may not have received cytotoxic chemotherapy within 2 weeks of first dose of
G-CSF (filgrastim) therapy, with exception of hydroxyurea, which is allowed for up to
24 hours prior to first dose of G-CSF, and intrathecal chemotherapy, which is allowed
prior to, or in the 1st 72 hours after start of G-CSF therapy

- The following amounts of time must have elapsed prior to entry on study:

- 2 weeks from local radiation therapy (XRT)

- 8 weeks from prior craniospinal or if > 50% of the pelvis has been irradiated

- 6 weeks must have elapsed if other bone marrow radiation has occurred

- Creatinine within normal range for age (per institutional defined lab value ranges)

- Direct bilirubin =< 1.5 upper limit of normal (ULN) age unless elevation thought to
be due or hepatic infiltration by the hematologic malignancy

- Alanine aminotransferase (ALT) < 5 x ULN age

- Adequate cardiac function as defined as shortening fraction of > 27% OR ejection
fraction of > 50%

- Patients must have a calculated QT (QTc) interval < 450 ms on baseline echocardiogram

- Patients must demonstrate a respiratory rate that is within normal limits for age,
measured when afebrile and at rest (measured for a full minute) and pulse oximetry >
93% on room air

- Signed informed consent

- Patient must have a life expectancy of at least 2 months

- Females of childbearing potential must have a negative serum pregnancy test performed
within 7 days prior to the start of treatment

- Females of childbearing potential and males should agree to use adequate
contraception (barrier method of birth control) prior to study entry and for the
duration of study participation

Exclusion Criteria:

- Recipient of prior allogeneic hematopoietic stem cell transplant (HCT)

- Patients with history of Down's syndrome, Fanconi anemia or other known marrow
failure condition

- Patients with central nervous system (CNS) 3 disease or symptomatic CNS2 disease are
not eligible

- Patients currently receiving other investigational drugs are not eligible

- Current concomitant chemotherapy, radiation therapy, or immunotherapy other than as
specified in the protocol with the exception of intrathecal chemotherapy; this
includes the tyrosine kinase inhibitor sorafenib which must not be initiated until
patient demonstrates count recovery

- Patients with a systemic fungal, bacterial, viral, or other infection not controlled
despite appropriate antibiotics or other treatment; uncontrolled systemic infections
require infectious disease consultation for verification

- Patients who are platelet refractory prior to initiation of protocol therapy;
platelet refractoriness is defined by platelet count < 50K when platelet count is
obtained 1 hour post platelet transfusion

- Pregnant or lactating patients

- Any significant concurrent disease, illness, or psychiatric disorder that would
compromise patient safety or compliance, interfere with consent, study participation,
follow up, or interpretation of study results