Sitagliptin Umbilical Cord Blood Transplant Study
A Phase II Trial of Inhibition of CD26 Peptidase Using Sitagliptin to Enhance Engraftment After Umbilical Cord Blood Transplantation for Adults With Hematological Malignancies
1 other identifier
interventional
29
1 country
1
Brief Summary
The main purpose of this trial is to study whether the drug sitagliptin can be given safely to patients undergoing umbilical cord blood transplantation to speed up engraftment (recovery of blood counts after transplant).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Mar 2009
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 16, 2009
CompletedFirst Posted
Study publicly available on registry
March 17, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedResults Posted
Study results publicly available
August 4, 2016
CompletedOctober 7, 2016
August 1, 2016
3.7 years
March 16, 2009
June 22, 2016
August 25, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Cumulative Incidence of Patients With Engraftment by Day +30 Following Transplant
Evaluate the efficacy of CD26/DPP-IV inhibition in increasing the cumulative incidence of adult patients with hematological malignancies engrafting by day +30 following transplantation of UCB by 30 percent. The cumulative incidence of patients achieving this will be reported. The value of the estimate will be from bootstrapping 1000 samples with replacement of the data and the 95% confidence interval will be calculated using the percentile method.
Transplant (Day 0) through Day +30
Secondary Outcomes (3)
Time to Neutrophil Engraftment
Transplant (Day 0) up to 1 year
Time to Platelet Engraftment
Transplant (Day 0) up to 1 year
Treatment Related Adverse Events Grade 3 or Higher for Non-hematological Toxicity
Transplant (Day 0) up to 3 years
Study Arms (3)
Sitagliptin once per day
EXPERIMENTAL600 mg sitagliptin once per day orally starting on Day -1 for a total of 4 doses
Sitagliptin twice per day
EXPERIMENTAL600 mg sitagliptin twice per day orally starting on Day -1 for a total of 8 doses
Sitagliptin three times per day
EXPERIMENTAL600 mg sitagliptin three times per day orally starting on Day -1 for a total of 12 doses
Interventions
600 mg sitagliptin taken orally per the schedule listed in each of the three separate arms.
Eligibility Criteria
You may qualify if:
- Patients must have one of the following disease types with disease-specific features as outlined in the protocol:
- Acute myeloid leukemia (AML)
- Acute lymphoblastic leukemia (ALL)
- Myelodysplasia
- Chronic myelogenous leukemia
- 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
- Hodgkin's lymphoma
- Relapsed Multiple Myeloma
- At least 35 days following start of preceding leukemia induction cytotoxic chemotherapy
- Patient age 18-55 years
- Karnofsky Performance status ≥ 70%
- No availability of a 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 with unstable disease who are in danger of significant disease progression while waiting to procure volunteer donor cells will be eligible to be treated on this protocol, even if a matched donor is available.
- Patients must have a matched or partially matched UCB unit with greater than 1.8 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).
- +3 more criteria
You may not qualify if:
- Symptomatic uncontrolled coronary artery disease or congestive heart failure.
- Severe hypoxemia with room air PaO2 less than 70, supplemental oxygen dependence, or DLCO less than 50 percent 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IU Simon Cancer Center
Indianapolis, Indiana, 46202, United States
Related Publications (1)
Farag SS, Srivastava S, Messina-Graham S, Schwartz J, Robertson MJ, Abonour R, Cornetta K, Wood L, Secrest A, Strother RM, Jones DR, Broxmeyer HE. In vivo DPP-4 inhibition to enhance engraftment of single-unit cord blood transplants in adults with hematological malignancies. Stem Cells Dev. 2013 Apr 1;22(7):1007-15. doi: 10.1089/scd.2012.0636. Epub 2013 Feb 15.
PMID: 23270493DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Sherif Farag
- Organization
- IndianaU
Study Officials
- PRINCIPAL INVESTIGATOR
Sherif Farag, MD, PhD
IU Simon Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 16, 2009
First Posted
March 17, 2009
Study Start
March 1, 2009
Primary Completion
November 1, 2012
Study Completion
February 1, 2015
Last Updated
October 7, 2016
Results First Posted
August 4, 2016
Record last verified: 2016-08