Clinical trial · Interventional
Multicenter Phase II of CD26 Using Sitagliptin for Engraftment After UBC Transplant
A Multicenter Phase II Trial of Inhibition of CD26 Peptidase Using Sitagliptin to Enhance Engraftment After Umbilical Cord Blood Transplantation for Adults With Hematological Malignancies
NCT01720264CI-TRIAL-00036411completedPhase 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 assess the efficacy and safety of sitagliptin in enhancing engraftment following umbilical cord blood transplantation (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 Lymphoid Leukemia | Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Hematopoetic Myelodysplasia | — | UNRESOLVED | — |
| Leukemia, Myelogenous, Chronic | Leukemia | ONTOLOGY_EXACT | 0.85 |
| Lymphoma, Non-Hodgkin | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sitagliptin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sitagliptin
- 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.
- interventionNames
- Drug: Sitagliptin
Primary outcomes (1)
- measure
- The Percent of Subjects Engrafting by Day +30 After Transplantation
- timeFrame
- Day 0 to Day +30 post transplant
- description
- Percent of patients and the 95% Binomial Confidence interval who were able to achieve neutrophils engraftment (defined as the date of the first of three consecutive ANC values obtained on different days after transplantation during which the absolute neutrophils count (ANC) is at least 0.5 x109/l) by 30 days following transplant.
Secondary outcomes (3)
- measure
- Time to Neutrophil Engraftment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available
No reference posted for this study.