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

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ClinicalTrials.gov Identifier: NCT01720264
Recruitment Status : Completed
First Posted : November 2, 2012
Results First Posted : January 8, 2019
Last Update Posted : January 8, 2019
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Sherif S. Farag, Indiana University

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).

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Acute Lymphoid Leukemia Hematopoetic Myelodysplasia Leukemia, Myelogenous, Chronic Lymphoma, Non-Hodgkin Drug: Sitagliptin Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : November 2, 2012
Actual Primary Completion Date : August 27, 2016
Actual Study Completion Date : December 15, 2017


Arm Intervention/treatment
Experimental: Sitagliptin
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.
Drug: Sitagliptin
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.
Other Name: Januvia




Primary Outcome Measures :
  1. The Percent of Subjects Engrafting by Day +30 After Transplantation [ Time Frame: Day 0 to Day +30 post transplant ]
    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 :
  1. Time to Neutrophil Engraftment [ Time Frame: Transplant (Day 0) up to 1 year ]
    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.

  2. Time to Platelet Engraftment [ Time Frame: Transplant (Day 0) up to 1 year ]
    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.

  3. Number of Subjects With Treatment Related Adverse Events Grade 3 and 4 Non-hematological Toxicities [ Time Frame: Day 0 up to 3 years ]
    Number of unique patients who had a treatment related (possible, probable or definite) non-hematological adverse event that was graded 3 or greater.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01720264


Locations
United States, Indiana
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
United States, New York
New York Medical College/Westchester Medical Center/Maria Fareri Children's Hosptial
Valhalla, New York, United States, 10595
Sponsors and Collaborators
Sherif S. Farag
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Sherif S Farag, MBBS, PhD Indiana University

Responsible Party: Sherif S. Farag, Lawrence H. Einhorn Professor of Oncology, Indiana University
ClinicalTrials.gov Identifier: NCT01720264     History of Changes
Other Study ID Numbers: 1208009261; HL112669
1R01HL112669-01 ( U.S. NIH Grant/Contract )
First Posted: November 2, 2012    Key Record Dates
Results First Posted: January 8, 2019
Last Update Posted: January 8, 2019
Last Verified: December 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Sitagliptin Phosphate
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Leukemia
Leukemia, Myeloid, Acute
Lymphoma, Non-Hodgkin
Myelodysplastic Syndromes
Preleukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Lymphoma
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Myeloproliferative Disorders
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action