Clinical trial · Interventional
Sitagliptin Umbilical Cord Blood Transplant Study
A Phase II Trial of Inhibition of CD26 Peptidase Using Sitagliptin to Enhance Engraftment After Umbilical Cord Blood Transplantation for Adults With Hematological Malignancies
NCT00862719CI-TRIAL-00024193completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Leukemia, Myelogenous, Chronic | Leukemia | ONTOLOGY_EXACT | 0.85 |
| Leukemia, Myeloid, Acute | Leukemia | ONTOLOGY_EXACT | 0.85 |
| Lymphoma, Non-Hodgkin | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Myelodysplasia | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sitagliptin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Sitagliptin once per day
- description
- 600 mg sitagliptin once per day orally starting on Day -1 for a total of 4 doses
- interventionNames
- Drug: Sitagliptin
- type
- EXPERIMENTAL
- label
- Sitagliptin twice per day
- description
- 600 mg sitagliptin twice per day orally starting on Day -1 for a total of 8 doses
- interventionNames
- Drug: Sitagliptin
- type
- EXPERIMENTAL
- label
- Sitagliptin three times per day
- description
- 600 mg sitagliptin three times per day orally starting on Day -1 for a total of 12 doses
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 59 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDFarag SS, Srivastava S, Messina-Graham S, Schwartz J, Robertson MJ, Abonour R, Cornetta K, Wood L, Secrest A, Strother RM, Jones DR, Broxmeyer HE. In vivo DPP-4 inhibition to enhance engraftment of single-unit cord blood transplants in adults with hematological malignancies. Stem Cells Dev. 2013 Apr 1;22(7):1007-15. doi: 10.1089/scd.2012.0636. Epub 2013 Feb 15. PMID 23270493