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

Completed · Phase 2

Conditions studied: Acute Myeloid Leukemia, Acute Lymphoid Leukemia, Hematopoetic Myelodysplasia, Leukemia, Myelogenous, Chronic, Lymphoma, Non-Hodgkin

In brief

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).

Key facts

Study ID

NCT01720264

Run by

Sherif S. Farag

People needed

15

Starts

2012-11-02

Expected to finish

2017-12-15

Last updated by the study team

2019-01-08

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Indiana University Melvin and Bren Simon Cancer Center — Indianapolis, Indiana, United States
• New York Medical College/Westchester Medical Center/Maria Fareri Children's Hosptial — Valhalla, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.