Multicenter Phase II of CD26 Using Sitagliptin for Engraftment After UBC Transplant

Umbilical cord blood (UCB) is more commonly used for transplantation in children but is being
used in adults more often. However, because adults are larger than children, the relatively
smaller stem cell dose in UCB is major limitation for transplantation in adults and
engraftment can be delayed. This study is trying to find out if the drug sitagliptin can be
used to increase and speed up engraftment in adults receiving UCB transplantation.

Inclusion Criteria:

- Patients must have one of the following disease types:

- Acute myeloid leukemia (AML) with disease features as described in the protocol.

- Acute lymphoblastic leukemia (ALL) with disease features as described in the
protocol.

- Myelodysplasia with disease features as described in the protocol.

- Chronic myelogenous leukemia (CML) with disease features as described in the
protocol.

- Patients with aggressive non-Hodgkin's lymphoma (NHL), including diffuse large
cell lymphoma, mediastinal B-cell lymphoma, transformed lymphoma, mantle cell
lymphoma, and peripheral T cell lymphoma, who also have one of the disease
features as described in the protocol.

- At least 35 days following start of preceding leukemia induction cytotoxic
chemotherapy.

- For patients in remission, there should be no readily available consenting HLA-matched
related donor who is either matched fully matched or mismatched at only one locus of
HLA-A, -B, and DRB1.

- No availability of a readily available HLA-matched volunteer unrelated donor (8 of 8
allele match at HLA-A, -B, -C and -DRB1).

- Patients must have a matched or partially matched UCB unit with >/= 2.5 x10^7
nucleated cells/kg of recipient weight at the time of cryopreservation.

- No current uncontrolled bacterial, viral or fungal infection (defined as currently
taking medication and progression of clinical symptoms).

- No HIV disease.

- Non pregnant and non-nursing.

- Required baseline laboratory values as described in the protocol.

- Signed written informed consent.

Exclusion Criteria:

- Symptomatic uncontrolled coronary artery disease or congestive heart failure.

- Severe hypoxemia with room air PaO2<70, supplemental oxygen dependence, or DLCO<50%
predicted.

- Patients with central nervous system (CNS) involvement refractory to intrathecal
chemotherapy.

- Prior allogeneic or autologous hematopoietic stem cell transplant in the last 6
months.

- Patients who are taking other insulin secretagogues and/or insulin.

- Patients who have hypersensitivity to sitagliptin.

- Patients with a history of pancreatitis, cholelithiasis, alcoholism, or fasting
hypertriglyceridemia (> 2 x ULN).