Phase 2
Completed N=15
Multicenter Phase II of CD26 Using Sitagliptin for Engraftment After UBC Transplant
Acute Myeloid Leukemia · leukemia · Hematopoetic Myelodysplasia · Lymphoma, Non-Hodgkin
Source: ClinicalTrials.gov NCT01720264 ↗
Enrolled (actual)
15
Serious AEs
60.0%
Results posted
Jan 2019
Primary outcomePrimary: The Percent of Subjects Engrafting by Day +30 After Transplantation — 100 percentage of participants
Summary
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percent of Subjects Engrafting by Day +30 After Transplantation |
100 | — |
| SECONDARY Time to Neutrophil Engraftment |
19 | — |
| SECONDARY Time to Platelet Engraftment |
52 | — |
| SECONDARY Number of Subjects With Treatment Related Adverse Events Grade 3 and 4 Non-hematological Toxicities |
— | — |
Eligibility Criteria
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 2 x ULN).
Data sourced from ClinicalTrials.gov (NCT01720264). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.