Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HL112669-01 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sitagliptin | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sitagliptin | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 0 to Day +30 post transplant |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Patients must have one of the following disease types:
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sherif S Farag, MBBS, PhD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | 46202 | United States | ||
Not provided
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Sitagliptin | Sitagliptin 600 mg q 12 hours PO for a total of 10 doses plus Total Body Irradiation (TBI) or Chemotherapy only. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Transplant With Sitagliptin for 15 Days |
|
| ||||||||||||||||||
| Post-transplant (Day 16) to 1 Year |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sitagliptin | Sitagliptin 600 mg q 12 hours PO for a total of 10 doses plus Total Body Irradiation or Chemotherapy only. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All patients who received treatment and were followed after transplant. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 0 to Day +30 post transplant |
|
Up to 3 years
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sitagliptin | Sitagliptin 600 mg q 12 hours PO for a total of 10 doses plus Total Body Irradiation or Chemotherapy only. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac arrest | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA (12.0) | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sherif Farag | IndianaU | (317) 278-0460 | ssfarag@iu.edu |
Not provided
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D009190 | Myelodysplastic Syndromes |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068900 | Sitagliptin Phosphate |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Transplant (Day 0) up to 1 year |
| 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. | Transplant (Day 0) up to 1 year |
| 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. | Day 0 up to 3 years |
| New York Medical College/Westchester Medical Center/Maria Fareri Children's Hosptial |
| Valhalla |
| New York |
| 10595 |
| United States |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | 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. | All patients who received treatment and survived at least 14 days after transplant. | Posted | Median | 95% Confidence Interval | days | Transplant (Day 0) up to 1 year |
|
|
|
| Secondary | 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. | All patients who received treatment and who achieved platelet recovery/engraftment of platelets. | Posted | Median | 95% Confidence Interval | days | Transplant (Day 0) up to 1 year |
|
|
|
| Secondary | 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. | All patients enrolled and received treatment. | Posted | Count of Participants | Participants | Day 0 up to 3 years |
|
|
|
| 9 |
| 15 |
| 15 |
| 15 |
| Colitis | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Multi-organ failure | General disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Hepatitis viral | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
|
| Infections and infestations - Other | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
|
| Meningitis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
|
| Acidosis | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Hydrocephalus | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Adult respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Pharyngeal mucositis | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Respiratory, thoracic and mediastinal disorders - Other | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Capillary leak syndrome | Vascular disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Cardiac disorders - Other | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Heart failure | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Ventricular arrhythmia | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Enterocolitis | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Gastrointestinal disorders - Other | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Lower gastrointestinal hemorrhage | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Mucositis oral | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Edema limbs | General disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Fever | General disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Localized edema | General disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Hepatobiliary disorders - Other | Hepatobiliary disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Bladder infection | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
|
| Encephalitis infection | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
|
| Infections and infestations - Other | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
|
| Rhinitis infective | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
|
| Salivary gland infection | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA (12.0) | Non-systematic Assessment |
|
| Alkaline phosphatase increased | Investigations | MedDRA (12.0) | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA (12.0) | Non-systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA (12.0) | Non-systematic Assessment |
|
| Creatinine increased | Investigations | MedDRA (12.0) | Non-systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA (12.0) | Non-systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA (12.0) | Non-systematic Assessment |
|
| Weight loss | Investigations | MedDRA (12.0) | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Encephalopathy | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Hydrocephalus | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Intracranial hemorrhage | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Nervous system disorders - Other | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Seizure | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Stroke | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Hematuria | Renal and urinary disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Menorrhagia | Reproductive system and breast disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Adult respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Laryngeal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Respiratory, thoracic and mediastinal disorders - Other | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (12.0) | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D001855 | Bone Marrow Diseases |
| D009196 | Myeloproliferative Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008223 | Lymphoma |
| D011719 |
| Pyrazines |