Trial Outcomes & Findings for Multicenter Phase II of CD26 Using Sitagliptin for Engraftment After UBC Transplant (NCT NCT01720264)
NCT ID: NCT01720264
Last Updated: 2019-01-08
Results Overview
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.
COMPLETED
PHASE2
15 participants
Day 0 to Day +30 post transplant
2019-01-08
Participant Flow
The study was stopped at 15 patients due to poor accrual. One patient subsequently found not to have met eligibility because she commenced treatment one day earlier than the prescribed 35-day interval from previous therapy is included in the analysis.
Participant milestones
| Measure |
Sitagliptin
Sitagliptin 600 mg q 12 hours PO for a total of 10 doses plus Total Body Irradiation (TBI) or Chemotherapy only.
|
|---|---|
|
Transplant With Sitagliptin for 15 Days
STARTED
|
15
|
|
Transplant With Sitagliptin for 15 Days
COMPLETED
|
14
|
|
Transplant With Sitagliptin for 15 Days
NOT COMPLETED
|
1
|
|
Post-transplant (Day 16) to 1 Year
STARTED
|
14
|
|
Post-transplant (Day 16) to 1 Year
COMPLETED
|
2
|
|
Post-transplant (Day 16) to 1 Year
NOT COMPLETED
|
12
|
Reasons for withdrawal
| Measure |
Sitagliptin
Sitagliptin 600 mg q 12 hours PO for a total of 10 doses plus Total Body Irradiation (TBI) or Chemotherapy only.
|
|---|---|
|
Transplant With Sitagliptin for 15 Days
Adverse Event
|
1
|
|
Post-transplant (Day 16) to 1 Year
Death
|
8
|
|
Post-transplant (Day 16) to 1 Year
Disease Progression
|
4
|
Baseline Characteristics
Multicenter Phase II of CD26 Using Sitagliptin for Engraftment After UBC Transplant
Baseline characteristics by cohort
| Measure |
Sitagliptin
n=15 Participants
Sitagliptin 600 mg q 12 hours PO for a total of 10 doses plus Total Body Irradiation or Chemotherapy only.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
40.9 years
STANDARD_DEVIATION 13.96 • n=99 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Day 0 to Day +30 post transplantPopulation: All patients who received treatment and were followed after 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.
Outcome measures
| Measure |
Sitagliptin
n=15 Participants
Sitagliptin 600 mg q 12 hours PO for a total of 10 doses plus Total Body Irradiation or Chemotherapy only.
|
|---|---|
|
The Percent of Subjects Engrafting by Day +30 After Transplantation
|
100 percentage of participants
Interval 78.0 to 100.0
|
SECONDARY outcome
Timeframe: Transplant (Day 0) up to 1 yearPopulation: All patients who received treatment and survived at least 14 days after transplant.
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.
Outcome measures
| Measure |
Sitagliptin
n=15 Participants
Sitagliptin 600 mg q 12 hours PO for a total of 10 doses plus Total Body Irradiation or Chemotherapy only.
|
|---|---|
|
Time to Neutrophil Engraftment
|
19 days
Interval 13.0 to 20.0
|
SECONDARY outcome
Timeframe: Transplant (Day 0) up to 1 yearPopulation: All patients who received treatment and who achieved platelet recovery/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 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.
Outcome measures
| Measure |
Sitagliptin
n=6 Participants
Sitagliptin 600 mg q 12 hours PO for a total of 10 doses plus Total Body Irradiation or Chemotherapy only.
|
|---|---|
|
Time to Platelet Engraftment
|
52 days
Interval 21.0 to 89.0
|
SECONDARY outcome
Timeframe: Day 0 up to 3 yearsPopulation: All patients enrolled and received treatment.
Number of unique patients who had a treatment related (possible, probable or definite) non-hematological adverse event that was graded 3 or greater.
Outcome measures
| Measure |
Sitagliptin
n=15 Participants
Sitagliptin 600 mg q 12 hours PO for a total of 10 doses plus Total Body Irradiation or Chemotherapy only.
|
|---|---|
|
Number of Subjects With Treatment Related Adverse Events Grade 3 and 4 Non-hematological Toxicities
|
0 Participants
|
Adverse Events
Sitagliptin
Serious adverse events
| Measure |
Sitagliptin
n=15 participants at risk
Sitagliptin 600 mg q 12 hours PO for a total of 10 doses plus Total Body Irradiation or Chemotherapy only.
|
|---|---|
|
Cardiac disorders
Cardiac arrest
|
6.7%
1/15 • Up to 3 years
|
|
Gastrointestinal disorders
Colitis
|
6.7%
1/15 • Up to 3 years
|
|
Gastrointestinal disorders
Oral pain
|
6.7%
1/15 • Up to 3 years
|
|
General disorders
Multi-organ failure
|
13.3%
2/15 • Up to 3 years
|
|
Infections and infestations
Hepatitis viral
|
6.7%
1/15 • Up to 3 years
|
|
Infections and infestations
Infections and infestations - Other
|
20.0%
3/15 • Up to 3 years
|
|
Infections and infestations
Meningitis
|
6.7%
1/15 • Up to 3 years
|
|
Infections and infestations
Sepsis
|
13.3%
2/15 • Up to 3 years
|
|
Metabolism and nutrition disorders
Acidosis
|
6.7%
1/15 • Up to 3 years
|
|
Metabolism and nutrition disorders
Anorexia
|
6.7%
1/15 • Up to 3 years
|
|
Metabolism and nutrition disorders
Dehydration
|
6.7%
1/15 • Up to 3 years
|
|
Nervous system disorders
Hydrocephalus
|
6.7%
1/15 • Up to 3 years
|
|
Renal and urinary disorders
Acute kidney injury
|
6.7%
1/15 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
6.7%
1/15 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.7%
1/15 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
6.7%
1/15 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
6.7%
1/15 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
13.3%
2/15 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
6.7%
1/15 • Up to 3 years
|
|
Vascular disorders
Capillary leak syndrome
|
6.7%
1/15 • Up to 3 years
|
Other adverse events
| Measure |
Sitagliptin
n=15 participants at risk
Sitagliptin 600 mg q 12 hours PO for a total of 10 doses plus Total Body Irradiation or Chemotherapy only.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
13.3%
2/15 • Up to 3 years
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
6.7%
1/15 • Up to 3 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
6.7%
1/15 • Up to 3 years
|
|
Cardiac disorders
Atrial fibrillation
|
6.7%
1/15 • Up to 3 years
|
|
Cardiac disorders
Cardiac disorders - Other
|
6.7%
1/15 • Up to 3 years
|
|
Cardiac disorders
Heart failure
|
6.7%
1/15 • Up to 3 years
|
|
Cardiac disorders
Pericardial effusion
|
6.7%
1/15 • Up to 3 years
|
|
Cardiac disorders
Sinus bradycardia
|
13.3%
2/15 • Up to 3 years
|
|
Cardiac disorders
Sinus tachycardia
|
6.7%
1/15 • Up to 3 years
|
|
Cardiac disorders
Ventricular arrhythmia
|
6.7%
1/15 • Up to 3 years
|
|
Gastrointestinal disorders
Abdominal pain
|
6.7%
1/15 • Up to 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
13.3%
2/15 • Up to 3 years
|
|
Gastrointestinal disorders
Enterocolitis
|
6.7%
1/15 • Up to 3 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
6.7%
1/15 • Up to 3 years
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
6.7%
1/15 • Up to 3 years
|
|
Gastrointestinal disorders
Mucositis oral
|
60.0%
9/15 • Up to 3 years
|
|
Gastrointestinal disorders
Nausea
|
6.7%
1/15 • Up to 3 years
|
|
Gastrointestinal disorders
Oral pain
|
6.7%
1/15 • Up to 3 years
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
1/15 • Up to 3 years
|
|
General disorders
Edema limbs
|
6.7%
1/15 • Up to 3 years
|
|
General disorders
Fever
|
20.0%
3/15 • Up to 3 years
|
|
General disorders
Localized edema
|
13.3%
2/15 • Up to 3 years
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other
|
13.3%
2/15 • Up to 3 years
|
|
Infections and infestations
Bladder infection
|
6.7%
1/15 • Up to 3 years
|
|
Infections and infestations
Encephalitis infection
|
6.7%
1/15 • Up to 3 years
|
|
Infections and infestations
Infections and infestations - Other
|
66.7%
10/15 • Up to 3 years
|
|
Infections and infestations
Lung infection
|
13.3%
2/15 • Up to 3 years
|
|
Infections and infestations
Rhinitis infective
|
6.7%
1/15 • Up to 3 years
|
|
Infections and infestations
Salivary gland infection
|
6.7%
1/15 • Up to 3 years
|
|
Infections and infestations
Sepsis
|
13.3%
2/15 • Up to 3 years
|
|
Infections and infestations
Sinusitis
|
6.7%
1/15 • Up to 3 years
|
|
Infections and infestations
Upper respiratory infection
|
13.3%
2/15 • Up to 3 years
|
|
Infections and infestations
Urinary tract infection
|
20.0%
3/15 • Up to 3 years
|
|
Investigations
Alanine aminotransferase increased
|
6.7%
1/15 • Up to 3 years
|
|
Investigations
Alkaline phosphatase increased
|
13.3%
2/15 • Up to 3 years
|
|
Investigations
Aspartate aminotransferase increased
|
20.0%
3/15 • Up to 3 years
|
|
Investigations
Blood bilirubin increased
|
40.0%
6/15 • Up to 3 years
|
|
Investigations
Creatinine increased
|
13.3%
2/15 • Up to 3 years
|
|
Investigations
Neutrophil count decreased
|
13.3%
2/15 • Up to 3 years
|
|
Investigations
Platelet count decreased
|
13.3%
2/15 • Up to 3 years
|
|
Investigations
Weight loss
|
6.7%
1/15 • Up to 3 years
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
5/15 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
13.3%
2/15 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
13.3%
2/15 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.7%
1/15 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.7%
1/15 • Up to 3 years
|
|
Nervous system disorders
Encephalopathy
|
20.0%
3/15 • Up to 3 years
|
|
Nervous system disorders
Hydrocephalus
|
6.7%
1/15 • Up to 3 years
|
|
Nervous system disorders
Intracranial hemorrhage
|
6.7%
1/15 • Up to 3 years
|
|
Nervous system disorders
Nervous system disorders - Other
|
6.7%
1/15 • Up to 3 years
|
|
Nervous system disorders
Seizure
|
6.7%
1/15 • Up to 3 years
|
|
Nervous system disorders
Stroke
|
6.7%
1/15 • Up to 3 years
|
|
Nervous system disorders
Syncope
|
6.7%
1/15 • Up to 3 years
|
|
Psychiatric disorders
Anxiety
|
6.7%
1/15 • Up to 3 years
|
|
Renal and urinary disorders
Acute kidney injury
|
20.0%
3/15 • Up to 3 years
|
|
Renal and urinary disorders
Hematuria
|
13.3%
2/15 • Up to 3 years
|
|
Reproductive system and breast disorders
Menorrhagia
|
6.7%
1/15 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
6.7%
1/15 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
6.7%
1/15 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
13.3%
2/15 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
33.3%
5/15 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
6.7%
1/15 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.7%
1/15 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
6.7%
1/15 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
13.3%
2/15 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
6.7%
1/15 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
6.7%
1/15 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.7%
1/15 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
6.7%
1/15 • Up to 3 years
|
|
Vascular disorders
Hypotension
|
33.3%
5/15 • Up to 3 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place