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

Sherif S. Farag

Status and phase

Completed

Phase 2

Conditions

Hematopoetic Myelodysplasia

Acute Lymphoid Leukemia

Lymphoma, Non-Hodgkin

Leukemia, Myelogenous, Chronic

Acute Myeloid Leukemia

Treatments

Drug: Sitagliptin

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01720264

1R01HL112669-01 (U.S. NIH Grant/Contract)

1208009261 HL112669;

Details and patient eligibility

About

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).

Full description

Umbilical cord blood (UCB) is more commonly used for transplantation in children but is being used in adults more often. However, because adults are larger than children, the relatively smaller stem cell dose in UCB is major limitation for transplantation in adults and engraftment can be delayed. This study is trying to find out if the drug sitagliptin can be used to increase and speed up engraftment in adults receiving UCB transplantation.

Enrollment

15 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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).