Clinical trial NCT01720264: Multicenter Phase II of CD26 Using Sitagliptin for Engraftment After UBC Transplant
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Myeloid Leukemia
Acute Lymphoid Leukemia
Hematopoetic Myelodysplasia
Leukemia, Myelogenous, Chronic
Lymphoma, Non-Hodgkin
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2012-11-02
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).

Detailed 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.

Eligibility 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).

Primary outcomes:
measure: The Percent of Subjects Engrafting by Day +30 After Transplantation
timeFrame: Day 0 to Day +30 post transplant
Secondary outcomes:
measure: Time to Neutrophil Engraftment
timeFrame: Transplant (Day 0) up to 1 year
measure: Time to Platelet Engraftment
timeFrame: Transplant (Day 0) up to 1 year
measure: Number of Subjects With Treatment Related Adverse Events Grade 3 and 4 Non-hematological Toxicities
timeFrame: Day 0 up to 3 years
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Melvin and Bren Simon Cancer Center
state: Indiana
city: Valhalla
country: United States
facility: New York Medical College/Westchester Medical Center/Maria Fareri Children's Hosptial
state: New York
Study officials:
affiliation: Indiana University
name: Sherif S Farag, MBBS, PhD
role: PRINCIPAL_INVESTIGATOR
References: