Phase 2
Completed N=29
Sitagliptin Umbilical Cord Blood Transplant Study
Leukemia, Myeloid, Acute · Acute Lymphoblastic Leukemia · Myelodysplasia · leukemia
Source: ClinicalTrials.gov NCT00862719 ↗
Enrolled (actual)
29
Serious AEs
69.0%
Results posted
Aug 2016
Primary outcomePrimary: Cumulative Incidence of Patients With Engraftment by Day +30 Following Transplant — 88 percentage of participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cumulative Incidence of Patients With Engraftment by Day +30 Following Transplant |
88 | — |
| SECONDARY Time to Neutrophil Engraftment |
21; 35; 51; 14 | — |
| SECONDARY Time to Platelet Engraftment |
77; 91; NA; NA | — |
| SECONDARY Treatment Related Adverse Events Grade 3 or Higher for Non-hematological Toxicity |
0; 0; 0; 1 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00862719). 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.