StemRegenin-1 Expanded vs Unexpanded UCB for High Risk Heme Malignancies

Inclusion Criteria:

- Must have a partially HLA matched UCB unit with a pre-cryopreserved TNC dose >2.5 x
107 per kilogram recipient weight. HLA matching is initially based on 4 of 6 HLA-A and
B (at low or intermediate resolution by molecular typing) and DRB1 (at high resolution
by molecular typing).

- Eligible Diseases

- Acute myelogenous leukemia (AML) at the following stages:

- Intermediate to high risk leukemia in first complete remission (CR1) based
on institutional criteria.

- Any second or subsequent CR.

- Secondary AML with prior malignancy that has been in remission for at least
12 months.

- Acute lymphocytic leukemia (ALL) at the following stages:

- High risk first remission.

1. Ph+ ALL, or

2. MLL rearrangement with slow early response at Day 14, or

3. Hypodiploidy (< 44 chromosomes or DNA index < 0.81), or

4. End of induction M3 bone marrow, or

5. End of induction M2 with M2-3 at Day 42.

- High risk second CR based on institutional criteria (eg, for children, bone
marrow relapse <36 months from induction or T-lineage bone marrow relapse or
very early isolated central nervous system (CNS) relapse <6 months from
diagnosis, or slow re-induction (stage M2-3 at day 28 after induction)
regardless of length remission.

- Any third or subsequent CR.

- Biphenotypic/undifferentiated leukemia in CR

- Chronic myelogenous leukemia (CML) excluding refractory blast crisis

- Myelodysplasia (MDS) IPSS Int-2 or High risk (i.e. RAEB, RAEBt) or refractory
anemia

- Other Inclusion Criteria

- Karnofsky score >70% (16 years and older) or a Lansky play score >70 (children
<16 years) - appendix II

- Adequate organ function defined as:

- Renal: Serum creatinine within normal range for age, or if serum creatinine
outside normal range for age, then renal function (creatinine clearance or
GFR) >70 mL/min/1.73 m2.

- Hepatic: Bilirubin ≤2.5 x mg/dL; AST, ALT, alkaline phosphatase <5 x upper
limit of normal,

- Pulmonary function: DLCO, FEV1, FEC (diffusion capacity) >50% of predicted
(corrected for hemoglobin); if unable to perform pulmonary function tests,
then normal O2 saturation on room air.

- Cardiac: Left ventricular ejection fraction at rest must be >45%

- Available 'back-up' HSPC graft (e.g, second partially HLA matched UCB unit,
haploidentical related donor).

- Voluntary written consent signed (adult or parental) before performance of any
study-related procedure not part of normal medical care

Exclusion Criteria:

- Pregnant or breast feeding. The agents used in this study may be teratogenic to a
fetus and there is no information on the excretion of agents into breast milk. Females
of childbearing potential must have a blood test or urine study within 14 days prior
to study enrollment to rule out pregnancy.

- Evidence of human immunodeficiency virus (HIV) infection or known HIV positive
serology.

- Active bacterial, viral or fungal infection (currently taking medication and
progression of clinical symptoms).

- Prior autologous or allogeneic transplant within past 12 months.

- Other active malignancy.

- Inability to receive TBI 1320 cGy (e.g., extensive prior therapy including >12 months
alkylator therapy or >6 months alkylator therapy with extensive radiation. Or prior
Y-90 ibritumomab (Zevalin) or I-131 tostumomab (Bexxar), as part of their salvage
therapy.