Sitagliptin Umbilical Cord Blood Transplant Study
Condition: Leukemia, Myeloid, Acute; Acute Lymphoblastic Leukemia; Myelodysplasia; Leukemia, Myelogenous, Chronic; Lymphoma, Non-Hodgkin
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Lymphoma, Non-Hodgkin; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Intervention: Sitagliptin
Intervention description: 600 mg sitagliptin taken orally per the schedule listed in each of the three separate arms.
Intervention MeSH terms: Sitagliptin Phosphate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Maximum age: 59 Years
Healthy volunteers: No

Summary:

      The main purpose of this trial is to study whether the drug sitagliptin can be given safely
      to patients undergoing umbilical cord blood transplantation to speed up engraftment (recovery
      of blood counts after transplant).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have one of the following disease types with disease-specific features
             as outlined in the protocol:

               -  Acute myeloid leukemia (AML)

               -  Acute lymphoblastic leukemia (ALL)

               -  Myelodysplasia

               -  Chronic myelogenous leukemia

               -  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

               -  Hodgkin's lymphoma

               -  Relapsed Multiple Myeloma

          -  At least 35 days following start of preceding leukemia induction cytotoxic
             chemotherapy

          -  Patient age 18-55 years

          -  Karnofsky Performance status ≥ 70%

          -  No availability of a 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 with unstable disease who are in
             danger of significant disease progression while waiting to procure volunteer donor
             cells will be eligible to be treated on this protocol, even if a matched donor is
             available.

          -  Patients must have a matched or partially matched UCB unit with greater than 1.8 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. Patients with immune dysfunction are at a significantly higher risk of
             infection from intensive immunosuppressive therapies.

          -  Non pregnant and non-nursing. Treatment under this protocol would expose a fetus to
             significant risks.

          -  Required baseline laboratory values as defined in the protocol

        Exclusion Criteria:

          -  Symptomatic uncontrolled coronary artery disease or congestive heart failure.

          -  Severe hypoxemia with room air PaO2 less than 70, supplemental oxygen dependence, or
             DLCO less than 50 percent 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