Sitagliptin Umbilical Cord Blood Transplant Study

• Status: Completed
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: All

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).

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

Details

• Lead Sponsor: Indiana University School of Medicine
• Treatments: Sitagliptin Phosphate

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