Multicenter Phase II of CD26 Using Sitagliptin for Engraftment After UBC Transplant

• Status: Completed
• Trial end date: 2017-12-15
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sherif S. Farag
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Sitagliptin Phosphate

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<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).