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
Study type: Interventional
Phase: Phase 2

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).
    

Detailed description: 
      Umbilical cord blood (UCB) is increasingly used as a source of stem cells for patients with
      blood cancers who need an allogeneic stem cell transplant (a transplant with stem cells from
      another person) but who have no suitably matched donors. The advantages of UCB are that (1)
      it is associated with less risk of transmitting an infection from a donor, (2) it can be more
      safely given even if not completely matched compared to bone marrow or blood stem cells, and
      (3) it is much more quickly available than unrelated donor bone marrow or blood stem cells.
      While more commonly used for transplantation in children, UCB is increasingly being used in
      adults. However, because they 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 investigating whether the drug sitagliptin can be used to increase and speed up
      engraftment in adults receiving UCB transplantation, overcoming the limitation of small stem
      cell doses associated with umbilical cord blood.

      Sitagliptin is a drug given in tablet form that has been recently approved by the Food and
      Drug Administration (FDA) for the treatment of certain patients with diabetes mellitus (a
      disease that results in high blood sugar). Sitagliptin has been given to both normal healthy
      volunteers and diabetic patients and has been found to be safe and well-tolerated. The drug
      improves control of blood sugar in diabetics by inhibiting an enzyme called "CD26/DPP-IV."
      Recent studies at Indiana University (and other centers) have shown that this same enzyme
      plays an important role in the way transplanted stem cells find their way to the bone marrow
      and engraft. Transplant studies in mice have found that inhibiting CD26/DPP-IV significantly
      increases the engraftment of stem cells. Based on these studies, it is believed that drugs
      that inhibit CD26/DPP-IV, such as sitagliptin, may also increase engraftment in patients who
      receive clinical stem cell transplants.
    

Intervention name(s): Sitagliptin
Intervention type(s): Drug
Intervention description(s): 600 mg sitagliptin taken orally per the schedule listed in each of the three separate arms.
Other intervention name(s): Januvia
Intervention MeSH terms: Sitagliptin Phosphate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment