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

Primary Purpose

Acute Myeloid Leukemia, Acute Lymphoid Leukemia, Hematopoetic Myelodysplasia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Sitagliptin
Sponsored by
Sherif S. Farag
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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).

Sites / Locations

  • Indiana University Melvin and Bren Simon Cancer Center
  • New York Medical College/Westchester Medical Center/Maria Fareri Children's Hosptial

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sitagliptin

Arm Description

Sitagliptin q 12 hours PO starting on Day -1 then given every 12 hours (total 10 doses) on Day 0, Day +1, +2 and Day +3.

Outcomes

Primary Outcome Measures

The Percent of Subjects Engrafting by Day +30 After Transplantation
Percent of patients and the 95% Binomial Confidence interval who were able to achieve neutrophils engraftment (defined as the date of the first of three consecutive ANC values obtained on different days after transplantation during which the absolute neutrophils count (ANC) is at least 0.5 x109/l) by 30 days following transplant.

Secondary Outcome Measures

Time to Neutrophil Engraftment
Time to neutrophil engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of neutrophils is defined as the time from day 0 to the date of the first of three consecutive days after transplantation during which the absolute neutrophils count (ANC) is at least 0.5 x109/l. Patients surviving at least 14 days after transplant will be evaluable for this endpoint. Patients who did not have neutrophil engraftment before death will be censored at the date of death. The median and 95% confidence intervals will be provided.
Time to Platelet Engraftment
Time to platelet engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of platelets is defined as the time from day 0 to the first of three consecutive Complete Blood Counts (CBCs) obtained on different days after transplantation during which the platelet count is at least 20 x109/l. The CBCs obtained should be at least seven days after the most recent platelet transfusion. Only patients who achieved engraftment of platelets will be included in the analysis. The median and 95% confidence intervals will be provided.
Number of Subjects With Treatment Related Adverse Events Grade 3 and 4 Non-hematological Toxicities
Number of unique patients who had a treatment related (possible, probable or definite) non-hematological adverse event that was graded 3 or greater.

Full Information

First Posted
October 30, 2012
Last Updated
December 17, 2018
Sponsor
Sherif S. Farag
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT01720264
Brief Title
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

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
November 2, 2012 (Actual)
Primary Completion Date
August 27, 2016 (Actual)
Study Completion Date
December 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sherif S. Farag
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia, Acute Lymphoid Leukemia, Hematopoetic Myelodysplasia, Leukemia, Myelogenous, Chronic, Lymphoma, Non-Hodgkin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sitagliptin
Arm Type
Experimental
Arm Description
Sitagliptin q 12 hours PO starting on Day -1 then given every 12 hours (total 10 doses) on Day 0, Day +1, +2 and Day +3.
Intervention Type
Drug
Intervention Name(s)
Sitagliptin
Other Intervention Name(s)
Januvia
Intervention Description
Sitagliptin q 12 hours PO starting on Day -1 then given every 12 hours (total 10 doses) on Day 0, Day +1, +2 and Day +3.
Primary Outcome Measure Information:
Title
The Percent of Subjects Engrafting by Day +30 After Transplantation
Description
Percent of patients and the 95% Binomial Confidence interval who were able to achieve neutrophils engraftment (defined as the date of the first of three consecutive ANC values obtained on different days after transplantation during which the absolute neutrophils count (ANC) is at least 0.5 x109/l) by 30 days following transplant.
Time Frame
Day 0 to Day +30 post transplant
Secondary Outcome Measure Information:
Title
Time to Neutrophil Engraftment
Description
Time to neutrophil engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of neutrophils is defined as the time from day 0 to the date of the first of three consecutive days after transplantation during which the absolute neutrophils count (ANC) is at least 0.5 x109/l. Patients surviving at least 14 days after transplant will be evaluable for this endpoint. Patients who did not have neutrophil engraftment before death will be censored at the date of death. The median and 95% confidence intervals will be provided.
Time Frame
Transplant (Day 0) up to 1 year
Title
Time to Platelet Engraftment
Description
Time to platelet engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of platelets is defined as the time from day 0 to the first of three consecutive Complete Blood Counts (CBCs) obtained on different days after transplantation during which the platelet count is at least 20 x109/l. The CBCs obtained should be at least seven days after the most recent platelet transfusion. Only patients who achieved engraftment of platelets will be included in the analysis. The median and 95% confidence intervals will be provided.
Time Frame
Transplant (Day 0) up to 1 year
Title
Number of Subjects With Treatment Related Adverse Events Grade 3 and 4 Non-hematological Toxicities
Description
Number of unique patients who had a treatment related (possible, probable or definite) non-hematological adverse event that was graded 3 or greater.
Time Frame
Day 0 up to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sherif S Farag, MBBS, PhD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University Melvin and Bren Simon Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
New York Medical College/Westchester Medical Center/Maria Fareri Children's Hosptial
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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