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Sponsored by: |
Indiana University School of Medicine |
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Information provided by: | Indiana University |
ClinicalTrials.gov Identifier: | NCT00862719 |
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).
Condition | Intervention | Phase |
---|---|---|
Leukemia, Myeloid, Acute Acute Lymphoblastic Leukemia Myelodysplasia Leukemia, Myelogenous, Chronic Lymphoma, Non-Hodgkin |
Drug: Sitagliptin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Trial of Inhibition of CD26 Peptidase Using Sitagliptin to Enhance Engraftment After Umbilical Cord Blood Transplantation for Adults With Hematological Malignancies |
Estimated Enrollment: | 35 |
Study Start Date: | March 2009 |
Estimated Study Completion Date: | March 2013 |
Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must have one of the following disease types:
Exclusion Criteria:
Contact: Robin O'Bryant, RN | 317-278-6476 | obryantr@iupui.edu |
Contact: Sherif Farag, MD, PhD | 317-274-0843 | ssfarag@iupui.edu |
United States, Indiana | |
IU Simon Cancer Center | Recruiting |
Indianapolis, Indiana, United States, 46202 | |
Contact: Robin O'Bryant, RN 317-278-6476 obryantr@iupui.edu | |
Contact: Sherif Farag, MD, PhD 317-274-0843 ssfarag@iupui.edu |
Principal Investigator: | Sherif Farag, MD, PhD | IU Simon Cancer Center |
Responsible Party: | IU Simon Cancer Center ( Sherif Farag, MD, PhD; Principal Investigator ) |
Study ID Numbers: | 0812-15; IUCRO-0223 |
Study First Received: | March 16, 2009 |
Last Updated: | March 16, 2009 |
ClinicalTrials.gov Identifier: | NCT00862719 History of Changes |
Health Authority: | United States: Institutional Review Board |
Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Precancerous Conditions Hematologic Diseases Myelodysplastic Syndromes Myeloproliferative Disorders Leukemia, Myeloid Leukemia, Myeloid, Acute Protease Inhibitors Sitagliptin |
Leukemia Lymphatic Diseases Dipeptidyl-Peptidase IV Inhibitors Preleukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive Bone Marrow Diseases Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Acute Lymphoblastic Leukemia |
Leukemia, Lymphoid Precancerous Conditions Molecular Mechanisms of Pharmacological Action Leukemia, Myeloid, Acute Leukemia Preleukemia Lymphoma Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Immune System Diseases Hematologic Diseases Myelodysplastic Syndromes |
Myeloproliferative Disorders Enzyme Inhibitors Leukemia, Myeloid Pharmacologic Actions Sitagliptin Protease Inhibitors Lymphatic Diseases Neoplasms Dipeptidyl-Peptidase IV Inhibitors Leukemia, Myelogenous, Chronic, BCR-ABL Positive Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Bone Marrow Diseases |