Multicenter Phase II of CD26 Using Sitagliptin for Engraftment After UBC Transplant
Condition: Acute Myeloid Leukemia; Acute Lymphoid Leukemia; Hematopoetic Myelodysplasia; Leukemia, Myelogenous, Chronic; Lymphoma, Non-Hodgkin
MeSH terms: Leukemia; Lymphoma, Non-Hodgkin; Leukemia, Lymphoid; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Myelodysplastic Syndromes
Intervention: Sitagliptin
Intervention description: Sitagliptin q 12 hours PO starting on Day -1 then given every 12 hours (total 10 doses) on Day 0, Day +1, +2 and Day +3.
Intervention MeSH terms: Sitagliptin Phosphate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      The main purpose of this trial is to assess the efficacy and safety of sitagliptin in
      enhancing engraftment following umbilical cord blood transplantation (recovery of blood
      counts after transplant).
    

Eligibility criteria:

        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).