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A Multicenter Phase II Trial of Inhibition of CD26 Peptidase Using Sitagliptin to Enhance Engraftment After Umbilical Cord Blood Transplantation for Adults With Hematological Malignancies


Phase 2
18 Years
60 Years
Not Enrolling
Both
Acute Myeloid Leukemia, Acute Lymphoid Leukemia, Hematopoetic Myelodysplasia, Leukemia, Myelogenous, Chronic, Lymphoma, Non-Hodgkin

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Trial Information

A Multicenter Phase II Trial of Inhibition of CD26 Peptidase Using Sitagliptin to Enhance Engraftment After Umbilical Cord Blood Transplantation for Adults With Hematological Malignancies


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.


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).

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The percent of subjects engrafting by day +30 after transplantation

Outcome Description:

The primary objective of this phase II study is to determine if systemic inhibition of CD26 can result in neutrophil engraftment in 70% or more of patients by day +30 after transplantation, with a rate of <50% considered unacceptable.

Outcome Time Frame:

Day 0 to Day +30 post transplant

Safety Issue:

No

Principal Investigator

Sherif S Farag, M.B.B.S., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Indiana University

Authority:

United States: Food and Drug Administration

Study ID:

1208009261; HL112669

NCT ID:

NCT01720264

Start Date:

November 2012

Completion Date:

Related Keywords:

  • Acute Myeloid Leukemia
  • Acute Lymphoid Leukemia
  • Hematopoetic Myelodysplasia
  • Leukemia, Myelogenous, Chronic
  • Lymphoma, Non-Hodgkin
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

Indiana University Melvin and Bren Simon Cancer CenterIndianapolis, Indiana  46202-5289