Graft vs Host DiseasePhase 2NCT02683525
Sitagliptin for Prevention of Acute Graft Versus-Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation
A Phase 2 study testing Sitagliptin in people with Graft vs Host Disease and Hematopoietic Stem Cell Transplantation, run by Sherif S. Farag at 2 sites in United States.
Trial summary
Primary Objective Evaluate the efficacy of sitagliptin in reducing the incidence of grade II-IV acute Graft Versus-Host Disease (GvHD) by day +100 post-transplant in patients undergoing allogeneic hematopoietic stem cell transplantation and receiving standard sirolimus and tacrolimus GvHD prophylaxis. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Graft vs Host Disease, Hematopoietic Stem Cell Transplantation
- What is being tested?
- Sitagliptin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Feb 2016to 1 Oct 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with any of the following hematologic malignancies:
- Acute myeloid leukemia (AML) with any of the following:
- In first remission (CR1) with intermediate risk or high-risk cytogenetic and/or molecular features.
- Patients in second or subsequent complete remission (CR2, CR3, etc.).
- Primary refractory or relapsed AML with no more than any one of the following adverse additional features according to modified CIBMTR criteria:49
- Duration of first CR < 6 months
Show all 50Show fewer
- Poor risk cytogenetics or molecular features (FLT-3 internal tandem duplication (ITD); complex karyotype with ≥3 clonal abnormalities, 5q-/-5, 7q-/-7, 11q23 abnormalities, inv(3), monosomal karyotype)
- Circulating peripheral blood blasts at time of enrollment
- Karnofsky performance status <90%
- Acute lymphoblastic leukemia (ALL) with any of the following:
- In CR1 or subsequent complete remission (CR2, CR3, etc.)
- Primary refractory or relapsed ALL with no more than one of the following adverse features according to modified CIBMTR criteria:49
- Second or subsequent relapse
- Bone marrow blasts >25% at time of enrollment
- Age >40 years
- Myelodysplasia with any of the following features:
- Refractory anemia with excess blasts type I (5-10% blasts) or II (11-20% blasts) in the bone marrow (RAEB I and II)
- Refractory cytopenia with multilineage dysplasia (RCMD) and poor risk cytogenetics (i.e., chromosome 7 abnormalities or complex karyotype with at least 3 abnormalities per clone)
- Chronic myelogenous leukemia (CML) with one of the following criteria:
- Accelerated phase, defined by any of the following:
- Blasts 10-19% in peripheral blood white cells or bone marrow
- Peripheral blood basophils at least 20%
- Persistent thrombocytopenia (<100 x 109/l) unrelated to therapy, or persistent thrombocytosis (>1000 x 109/l) unresponsive to therapy
- Increasing spleen size and increasing white blood cell (WBC) count unresponsive to therapy
- Cytogenetic evidence of clonal evolution (i.e., the appearance of an additional genetic abnormality that was not present in the initial specimen at the time of diagnosis of chronic phase)
- Chronic phase provided a complete hematologic remission was not achieved by 3 months or a complete cytogenetic remission by 18 months and the patient had received at least 2 tyrosine kinase inhibitors
- 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 following criteria:
- Failure to achieve complete remission to primary induction therapy
- Relapsed and refractory to at least one line of salvage systemic therapy
- Failed stem cell collection
- Patients with Hodgkin's lymphoma meeting one of the following criteria:
- Primary refractory (failure to achieve complete remission to primary induction therapy)
- Relapsed and refractory to at least one line of salvage systemic therapy
- Failed stem cell collection
- Patient age ≥ 18 to ≤ 60 years
- Karnofsky Performance status ≥ 70%
- Patients must also receive a full myeloablative preparative regimen (Patients treated with either total body irradiation (TBI)-based or high-dose chemotherapy only regimens are eligible other than high-dose busulfan containing regimens or regimens that include anti-thymocyte globulin or other T cell depleting antibodies)
- Patients receiving allogeneic peripheral blood stem cell (PBSC) grafts from HLA-matched (5/6 and 6/6 matches) siblings or from well matched unrelated donors (9/10 or 10/10 matches at HLA-A, B, C, DRB1 and DQB1 by high resolution typing) are included. All grafts will be unmanipulated (i.e., no T cell depleted or CD34 selected grafts).
- No uncontrolled bacterial, viral or fungal infection at time of enrollment defined as currently taking medication and progression of clinical symptoms
- No HIV disease (Patients with immune dysfunction are at a significantly higher risk of infection from intensive immunosuppressive therapies)
- Non-pregnant and non-nursing
- Required baseline values within 60 days prior to admission:
- LVEF ≥ 45%
- DLCO ≥ 50% of predicted (corrected for hemoglobin)
- Required baseline laboratory values within 16 days prior to admission:
- Estimated creatinine clearance ≥60 ml/min
- Serum total bilirubin ≤ 2 x upper limit of normal value (ULN)
- AST and ALT ≤ 2 x ULN (unless determined by treating physician to be related to underlying malignancy)
- Signed written informed consent (Patient must be capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent)
- Patients must otherwise fulfill institutional criteria for eligibility to undergo myeloablative allogeneic stem cell transplantation
Who cannot join
- 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 active central nervous system involvement
- Prior allogeneic or autologous hematopoietic stem cell transplant in past 12 months
- Patients with diabetes mellitus requiring insulin secretagogues and/or insulin
- Patients with hypertriglyceridemia with serum triglyceride level ≥500 mg/d (lipid lowering drugs may be used to control level)
Show all 9Show fewer
- Patients with a history of pancreatitis
- Patients with symptomatic cholelithiasis
- Patients with a current dependence on alcohol (characterized by a physical addiction to alcohol that interferes with physical or mental health, and social, family or job responsibilities)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Indiana University Health Hospital
Indianapolis, Indiana, 46202
Indiana University Health Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
About this study
Official title: Phase II Trial of Inhibition of Dipeptidyl Peptidase (DPP)-4 With Sitagliptin for the Prevention of Acute Graft Versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplantation
Primary Objective
Evaluate the efficacy of sitagliptin in reducing the incidence of grade II-IV acute Graft Versus-Host Disease (GvHD) by day +100 post-transplant in patients undergoing allogeneic hematopoietic stem cell transplantation and receiving standard sirolimus and tacrolimus GvHD prophylaxis.
Read more
Secondary Objectives
The following descriptive secondary objectives will be studied:
- Describe the tolerability and potential toxicity of sitagliptin.
- Describe the cumulative incidence of grades II-IV acute GvHD by day +100.
- Describe the cumulative incidence of grades III-IV acute GvHD.
- Describe the engraftment kinetics of absolute neutrophil count and platelets.
- Describe the incidence of infections occurring during the 100 days post-transplant.
- Describe non-relapse mortality (NRM) at day +30, +100, and 1 year post-transplant.
- Describe overall survival.
- Describe the incidence of chronic GvHD.
- Describe the cumulative incidence of relapse of the primary hematological malignancy.
Read the detailed description
This is an open label phase II study in patients undergoing allogeneic hematopoietic stem cell transplantation and receiving standard sirolimus and tacrolimus GvHD prophylaxis. Although the myeloablative preparative regimen is not prescribed, it is anticipated that most patients will receive total body irradiation (TBI) plus etoposide (TBI/VP16), or high-dose thiotepa plus cyclophosphamide according to institutional standards. Regardless of the preparative regimen, all patients will receive the following regimen for GvHD prophylaxis, which includes the study drug sitagliptin:
Day -3: Tacrolimus is initiated on day -3 with a suggested starting dose of 0.01 mg/kg/day IV as a continuous infusion and them modified to target a serum level of 5-10 ng/ml. Serum levels should be monitored at least twice weekly until discharge, then at times of outpatient clinic visits according to institutional practice. Tacrolimus may be switched to PO dosing when the patient is able to tolerate oral intake satisfactorily. Note that concurrent use of agents such as itraconazole, voriconazole or fluconazole (at doses > 200 mg) may inhibit the metabolism of tacrolimus, and thus increase tacrolimus levels. Initial dosing may be decreased in order to account for increased levels related to use of 'azole' agents. In addition, it is recommended to check tacrolimus levels twice weekly when these agents are initiated concurrently.
Sirolimus is started on day -3 with a suggested loading dose of 1 mg PO, then 0.5 mg/day PO single dose from day -2 to maintain a target serum level of 5-10 ng/ml. Serum levels should be monitored twice weekly until discharge, then at times of outpatient clinic visits according to institutional practice. Initial dosing may be decreased in order to account for increased levels related to use of 'azole' agents.
Day -1: Sitagliptin 600 mg q 12 hours PO starting on Day -1 to be administered between 8:00 am and 10:00 am then given every 12 hours (total 32 doses) through day +14.
In the absence of acute GvHD, begin tapering of both tacrolimus and sirolimus on Day +100 as tolerated with a goal of stopping by Day +180. The rate of taper may be adjusted for presence of signs and symptoms of GvHD. Mycophenolate mofetil may be substituted for tacrolimus or sirolimus if any toxicity related to these drugs arises (e.g., renal failure, hemolytic microangiopathy, allergic rash, etc.).
- Being tested
- Sitagliptin
- Keywords
- Allogeneic, Sitagliptin
- Medical subject headings
- Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SitagliptinDrug
600 mg ever 12 hours by mouth will be given starting the day before transplant through day +14 after transplant
| Study group | Role | What they receive |
|---|---|---|
| Sitagliptin | Experimental | Sitagliptin 600 mg q 12 hours PO starting on Day -1 before transplant to be administered between 8:00 am and 10:00 am then given every 12 hours (total 32 doses) through day +14. Receives: Drug: Sitagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients With Grade II-IV Acute GvHD by Day +100 Following Transplant
Percent of patients and the 95% Confidence interval who did not have Grade II-IV Acute GvHD by 100 days following transplant. Since the study completed the two-phase design, proper inference was used to generate the confidence interval (Koyama and Chen). Only patients who were on the study for at least 100 days post transplant were included in the analysis.
Measured: up to 100 days
Secondary outcomes (10)
Percentage of Patients With Grade II-IV Acute GvHD at Day +100
Kaplan-Meier methods will be used to conduct a competing risk analysis. Time until grade II-IV acute GvHD will be calculated from transplant until grade II-IV acute GvHD or death from GvHD. Patients who relapsed or died from causes other than GvHD will be considered a competing risk and calculated from time of transplant until relapse or death. Otherwise, patients will be censored and calculated from transplant until the last known alive date. The cumulative incidence percentage of grade II-IV acute GvHD at day +100 was calculated along with a 95% confidence interval.
Measured: 100 days from transplant
Number of Patients With Treatment Related Adverse Events Grade 3 or Higher for Non-hematological Toxicity
Number of unique patients who had a treatment related (possible, probable or definite) non-hematological adverse event that was graded 3 or greater.
Measured: up to 2 months
Percentage of Patients With Grade III-IV Acute GvHD at Day +100
Kaplan-Meier methods will be used to conduct a competing risk analysis. Time until grade III-IV acute GvHD will be calculated from transplant until grade III-IV acute GvHD or death from GvHD. Patients who relapsed or died from causes other than GvHD will be considered a competing risk and calculated from time of transplant until relapse or death. Otherwise, patients will be censored and calculated from transplant until the last known alive date. The cumulative incidence percentage of grade II-IV acute GvHD at day +100 was calculated along with a 95% confidence interval.
Measured: 100 days from transplant
Median Time to Engraftment of Neutrophils
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 who did not have neutrophil engraftment before death will be censored at the date of death. The median and 95% confidence intervals were calculated.
Measured: up to 1 month
Median Time to Engraftment of Platelets
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 seven 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. The median and 95% confidence intervals were calculated.
Measured: up to 4 months
Number of Unique Patients With Infections by Day +100
Number of unique patients who had each type of infection (i.e., viral, bacterial, fungal, etc.) during the 100 days post transplant. A patient could have more than one type of infection.
Measured: 100 days from transplant
Percentage of Patients With Non-relapse Mortality (NRM) at +1 Year
Kaplan-Meier methods will be used to conduct a competing risk analysis. Time until non-relapse death will be calculated from transplant until death. Patients who died from relapse will be considered a competing risk and calculated from time of transplant until death. Otherwise, patients will be censored and calculated from transplant until the last known alive date. The cumulative incidence percentage of non-relapse mortality at day +365 was calculated along with a 95% confidence interval.
Measured: 1 year from transplant
Percentage of Patients Surviving at +1 Year
Duration of time from the start of treatment to time of death due to any causes. Patients who do not die will be censored on their last known alive date. Kaplan-Meier methods will be used and the median and 95% confidence intervals will be calculated. The cumulative incidence percentage of survival at day +365 was calculated along with a 95% confidence interval.
Measured: 1 year from transplant
Percentage of Patients Diagnosed With Chronic GvHD at 1 Year
Patients surviving at least 100 days will be evaluable for chronic GvHD. The cumulative incidence of chronic GvHD (total, and mild, moderate, severe) will be described using deaths from causes other than chronic GvHD considered as a competing risk. Kaplan-Meier methods will be used to conduct a competing risk analysis. Time until chronic GvHD will be calculated from transplant until chronic GvHD or death from GvHD. Patients who relapsed or died from causes other than GvHD will be considered a competing risk and calculated from time of transplant until relapse or death. Otherwise, patients will be censored and calculated from transplant until the last known alive date. The cumulative incidence percentage at 1 year will calculated along with a 95% confidence interval.
Measured: 1 year from transplant
Percentage of Patients With Relapse of the Primary Hematological Malignancy at 1 Year
Kaplan-Meier methods will be used to conduct a competing risk analysis. Time until relapse will be calculated from transplant until relapse or death from relapse. Patients who died from causes other than relapse will be considered a competing risk and calculated from time of transplant until death. Otherwise, patients will be censored and calculated from transplant until the last known alive date. The cumulative incidence percentage of relapse at day +365 was calculated along with a 95% confidence interval.
Measured: 1 year from transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2016 (estimated)
- Study start3 Feb 2016
- Primary completion13 Feb 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Graft vs Host DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sherif S. Farag
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sherif S. Farag, Indiana University
- Investigators
- Sherif Farag, MD, PhD, Principal investigator, Indiana University School of Medicine, Indiana University Simon Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02683525
- Sponsor's protocol ID
- IUSCC-0522
- Status last verified
- Jan 2021
- First submitted
- 2 Feb 2016
- Last updated
- 22 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Farag SS, Abu Zaid M, Schwartz JE, Thakrar TC, Blakley AJ, Abonour R, Robertson MJ, Broxmeyer HE, Zhang S. Dipeptidyl Peptidase 4 Inhibition for Prophylaxis of Acute Graft-versus-Host Disease. N Engl J Med. 2021 Jan 7;384(1):11-19. doi: 10.1056/NEJMoa2027372.
PubMed 33406328
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Inhibition of Dipeptidyl Peptidase (DPP)-4 With Sitagliptin for the Prevention of Acute Graft Versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT02683525
- Acronym / sponsor ID
- IUSCC-0522
- Keywords
- Allogeneic, Sitagliptin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Sherif S. FaragUniversity, hospital or other
- Study start
- 3 Feb 2016 (actual)
- Primary completion
- 13 Feb 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 17 Feb 2016 (estimated)
- Results
- Posted 29 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objective
Evaluate the efficacy of sitagliptin in reducing the incidence of grade II-IV acute Graft Versus-Host Disease (GvHD) by day +100 post-transplant in patients undergoing allogeneic hematopoietic stem cell transplantation and receiving standard sirolimus and tacrolimus GvHD prophylaxis.
Secondary Objectives
The following descriptive secondary objectives will be studied:
- Describe the tolerability and potential toxicity of sitagliptin.
- Describe the cumulative incidence of grades II-IV acute GvHD by day +100.
- Describe the cumulative incidence of grades III-IV acute GvHD.
- Describe the engraftment kinetics of absolute neutrophil count and platelets.
- Describe the incidence of infections occurring during the 100 days post-transplant.
- Describe non-relapse mortality (NRM) at day +30, +100, and 1 year post-transplant.
- Describe overall survival.
- Describe the incidence of chronic GvHD.
- Describe the cumulative incidence of relapse of the primary hematological malignancy.
Detailed description
This is an open label phase II study in patients undergoing allogeneic hematopoietic stem cell transplantation and receiving standard sirolimus and tacrolimus GvHD prophylaxis. Although the myeloablative preparative regimen is not prescribed, it is anticipated that most patients will receive total body irradiation (TBI) plus etoposide (TBI/VP16), or high-dose thiotepa plus cyclophosphamide according to institutional standards. Regardless of the preparative regimen, all patients will receive the following regimen for GvHD prophylaxis, which includes the study drug sitagliptin:
Day -3: Tacrolimus is initiated on day -3 with a suggested starting dose of 0.01 mg/kg/day IV as a continuous infusion and them modified to target a serum level of 5-10 ng/ml. Serum levels should be monitored at least twice weekly until discharge, then at times of outpatient clinic visits according to institutional practice. Tacrolimus may be switched to PO dosing when the patient is able to tolerate oral intake satisfactorily. Note that concurrent use of agents such as itraconazole, voriconazole or fluconazole (at doses > 200 mg) may inhibit the metabolism of tacrolimus, and thus increase tacrolimus levels. Initial dosing may be decreased in order to account for increased levels related to use of 'azole' agents. In addition, it is recommended to check tacrolimus levels twice weekly when these agents are initiated concurrently.
Sirolimus is started on day -3 with a suggested loading dose of 1 mg PO, then 0.5 mg/day PO single dose from day -2 to maintain a target serum level of 5-10 ng/ml. Serum levels should be monitored twice weekly until discharge, then at times of outpatient clinic visits according to institutional practice. Initial dosing may be decreased in order to account for increased levels related to use of 'azole' agents.
Day -1: Sitagliptin 600 mg q 12 hours PO starting on Day -1 to be administered between 8:00 am and 10:00 am then given every 12 hours (total 32 doses) through day +14.
In the absence of acute GvHD, begin tapering of both tacrolimus and sirolimus on Day +100 as tolerated with a goal of stopping by Day +180. The rate of taper may be adjusted for presence of signs and symptoms of GvHD. Mycophenolate mofetil may be substituted for tacrolimus or sirolimus if any toxicity related to these drugs arises (e.g., renal failure, hemolytic microangiopathy, allergic rash, etc.).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sitagliptin | Experimental | Drug: SitagliptinSitagliptin 600 mg q 12 hours PO starting on Day -1 before transplant to be administered between 8:00 am and 10:00 am then given every 12 hours (total 32 doses) through day +14. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (50 listed)
- Patients with any of the following hematologic malignancies:
- Acute myeloid leukemia (AML) with any of the following:
- Acute lymphoblastic leukemia (ALL) with any of the following:
- Myelodysplasia with any of the following features:
- Chronic myelogenous leukemia (CML) with one of the following criteria:
Key exclusion criteria (9 listed)
- 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 active central nervous system involvement
- Prior allogeneic or autologous hematopoietic stem cell transplant in past 12 months
- Patients with diabetes mellitus requiring insulin secretagogues and/or insulin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sitagliptin600 mg ever 12 hours by mouth will be given starting the day before transplant through day +14 after transplant | Drug | Sitagliptin |
Primary outcome
Percentage of Patients With Grade II-IV Acute GvHD by Day +100 Following Transplant
Time frame: up to 100 days
Percent of patients and the 95% Confidence interval who did not have Grade II-IV Acute GvHD by 100 days following transplant. Since the study completed the two-phase design, proper inference was used to generate the confidence interval (Koyama and Chen). Only patients who were on the study for at least 100 days post transplant were included in the analysis.
10 secondary outcomes
Percentage of Patients With Grade II-IV Acute GvHD at Day +100
Time frame: 100 days from transplant
Number of Patients With Treatment Related Adverse Events Grade 3 or Higher for Non-hematological Toxicity
Time frame: up to 2 months
Percentage of Patients With Grade III-IV Acute GvHD at Day +100
Time frame: 100 days from transplant
Median Time to Engraftment of Neutrophils
Time frame: up to 1 month
Median Time to Engraftment of Platelets
Time frame: up to 4 months
Number of Unique Patients With Infections by Day +100
Time frame: 100 days from transplant
Percentage of Patients With Non-relapse Mortality (NRM) at +1 Year
Time frame: 1 year from transplant
Percentage of Patients Surviving at +1 Year
Time frame: 1 year from transplant
Percentage of Patients Diagnosed With Chronic GvHD at 1 Year
Time frame: 1 year from transplant
Percentage of Patients With Relapse of the Primary Hematological Malignancy at 1 Year
Time frame: 1 year from transplant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33406328Farag SS, Abu Zaid M, Schwartz JE, Thakrar TC, Blakley AJ, Abonour R, Robertson MJ, Broxmeyer HE, Zhang S. Dipeptidyl Peptidase 4 Inhibition for Prophylaxis of Acute Graft-versus-Host Disease. N Engl J Med. 2021 Jan 7;384(1):11-19. doi: 10.1056/NEJMoa2027372.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sherif Farag, MD, PhD principal investigator
Indiana University School of Medicine, Indiana University Simon Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sitagliptin in people with Graft vs Host Disease and Hematopoietic Stem Cell Transplantation, run by Sherif S. Farag at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 50 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients With Grade II-IV Acute GvHD by Day +100 Following Transplant (time frame: up to 100 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02683525, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2021.