Trial Outcomes & Findings for Study of TelmisartanFor the Prevention of Acute GVHD Post Allogeneic Hematopoietic Stem Cell Transplantation (NCT NCT02338232)
NCT ID: NCT02338232
Last Updated: 2024-05-01
Results Overview
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
32 participants
Primary outcome timeframe
100 days post-transplant
Results posted on
2024-05-01
Participant Flow
Participant milestones
| Measure |
160 mg Telmisartan
60 patients will receive 160 of Telmisartan (2 80 mg tablets) for 101 days
Telmisartan
|
|---|---|
|
Overall Study
STARTED
|
32
|
|
Overall Study
COMPLETED
|
21
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
160 mg Telmisartan
60 patients will receive 160 of Telmisartan (2 80 mg tablets) for 101 days
Telmisartan
|
|---|---|
|
Overall Study
Screen Failure
|
3
|
|
Overall Study
Withdrawal by Subject
|
6
|
|
Overall Study
Adverse Event
|
2
|
Baseline Characteristics
Study of TelmisartanFor the Prevention of Acute GVHD Post Allogeneic Hematopoietic Stem Cell Transplantation
Baseline characteristics by cohort
| Measure |
160 mg Telmisartan
n=29 Participants
60 patients will receive 160 of Telmisartan (2 80 mg tablets) for 101 days
Telmisartan
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
|
Age, Continuous
|
54.33 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 100 days post-transplantOutcome measures
| Measure |
160 mg Telmisartan
n=27 Participants
60 patients will receive 160 of Telmisartan (2 80 mg tablets) for 101 days
Telmisartan
|
|---|---|
|
Number of Subjects With Grade 3 or Greater Acute Graft vs. Host Disease (GVHD) in Patients Receiving Allogeneic HCT.
|
1 Participants
|
SECONDARY outcome
Timeframe: 180 days post- transplantOutcome measures
| Measure |
160 mg Telmisartan
n=27 Participants
60 patients will receive 160 of Telmisartan (2 80 mg tablets) for 101 days
Telmisartan
|
|---|---|
|
Number of Subjects With Grade III-IV Hypotension as Per the National Cancer Institute's Common Terminology
|
6 Participants
|
Adverse Events
160 mg Telmisartan
Serious events: 8 serious events
Other events: 24 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
160 mg Telmisartan
n=29 participants at risk
60 patients will receive 160 of Telmisartan (2 80 mg tablets) for 101 days
Telmisartan
|
|---|---|
|
General disorders
Pain
|
3.4%
1/29 • Number of events 1 • From time of consent through +180 days post transplant
|
|
General disorders
Hospitalization
|
10.3%
3/29 • Number of events 3 • From time of consent through +180 days post transplant
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
3.4%
1/29 • Number of events 1 • From time of consent through +180 days post transplant
|
|
Blood and lymphatic system disorders
Primary Graft Failure
|
3.4%
1/29 • Number of events 1 • From time of consent through +180 days post transplant
|
|
Infections and infestations
Sepsis
|
6.9%
2/29 • Number of events 2 • From time of consent through +180 days post transplant
|
Other adverse events
| Measure |
160 mg Telmisartan
n=29 participants at risk
60 patients will receive 160 of Telmisartan (2 80 mg tablets) for 101 days
Telmisartan
|
|---|---|
|
Gastrointestinal disorders
Abdominal Cramping
|
6.9%
2/29 • Number of events 2 • From time of consent through +180 days post transplant
|
|
Gastrointestinal disorders
Abdominal Pail
|
6.9%
2/29 • Number of events 2 • From time of consent through +180 days post transplant
|
|
Immune system disorders
Acute GVHD
|
3.4%
1/29 • Number of events 1 • From time of consent through +180 days post transplant
|
|
Immune system disorders
Acute GVHD (GI)
|
3.4%
1/29 • Number of events 1 • From time of consent through +180 days post transplant
|
|
Immune system disorders
Acute GVHD (Liver)
|
3.4%
1/29 • Number of events 1 • From time of consent through +180 days post transplant
|
|
Immune system disorders
Acute GVHD (Skin and GI)
|
3.4%
1/29 • Number of events 1 • From time of consent through +180 days post transplant
|
|
Immune system disorders
Acute GVHD (Skin)
|
6.9%
2/29 • Number of events 2 • From time of consent through +180 days post transplant
|
|
Renal and urinary disorders
Acute Kidney Injury
|
3.4%
1/29 • Number of events 1 • From time of consent through +180 days post transplant
|
|
Nervous system disorders
Acute Mental Status Change
|
3.4%
1/29 • Number of events 1 • From time of consent through +180 days post transplant
|
|
Infections and infestations
Adeno Viremia
|
6.9%
2/29 • Number of events 3 • From time of consent through +180 days post transplant
|
|
Blood and lymphatic system disorders
Anemia
|
3.4%
1/29 • Number of events 1 • From time of consent through +180 days post transplant
|
|
Metabolism and nutrition disorders
Anorexia
|
17.2%
5/29 • Number of events 6 • From time of consent through +180 days post transplant
|
|
Psychiatric disorders
Anxiety
|
3.4%
1/29 • Number of events 1 • From time of consent through +180 days post transplant
|
|
Infections and infestations
BK Viremia
|
10.3%
3/29 • Number of events 3 • From time of consent through +180 days post transplant
|
|
Gastrointestinal disorders
Bloating
|
3.4%
1/29 • Number of events 1 • From time of consent through +180 days post transplant
|
|
General disorders
Chills
|
3.4%
1/29 • Number of events 1 • From time of consent through +180 days post transplant
|
|
Immune system disorders
Chronic GVHD
|
6.9%
2/29 • Number of events 2 • From time of consent through +180 days post transplant
|
|
Immune system disorders
Chronic GVHD (skin/liver, ocular, oral mucosa)
|
3.4%
1/29 • Number of events 1 • From time of consent through +180 days post transplant
|
|
Infections and infestations
CMV Reactivation
|
3.4%
1/29 • Number of events 1 • From time of consent through +180 days post transplant
|
|
Infections and infestations
CMV Viremia
|
3.4%
1/29 • Number of events 1 • From time of consent through +180 days post transplant
|
|
Investigations
Creatinine increased
|
10.3%
3/29 • Number of events 4 • From time of consent through +180 days post transplant
|
|
Renal and urinary disorders
Cystitis
|
3.4%
1/29 • Number of events 1 • From time of consent through +180 days post transplant
|
|
Vascular disorders
Deep vein thrombosis
|
6.9%
2/29 • Number of events 2 • From time of consent through +180 days post transplant
|
|
Blood and lymphatic system disorders
Delayed Engraftment
|
3.4%
1/29 • Number of events 1 • From time of consent through +180 days post transplant
|
|
Gastrointestinal disorders
Diarrhea
|
24.1%
7/29 • Number of events 8 • From time of consent through +180 days post transplant
|
|
Gastrointestinal disorders
Diarrhea (Intermittent)
|
3.4%
1/29 • Number of events 1 • From time of consent through +180 days post transplant
|
|
Nervous system disorders
Dizziness
|
3.4%
1/29 • Number of events 1 • From time of consent through +180 days post transplant
|
|
Nervous system disorders
Dizziness (Intermittent)
|
3.4%
1/29 • Number of events 1 • From time of consent through +180 days post transplant
|
|
Eye disorders
Dry eyes
|
3.4%
1/29 • Number of events 1 • From time of consent through +180 days post transplant
|
|
Gastrointestinal disorders
Dry Mouth
|
3.4%
1/29 • Number of events 1 • From time of consent through +180 days post transplant
|
|
Nervous system disorders
Dysgeusia
|
20.7%
6/29 • Number of events 6 • From time of consent through +180 days post transplant
|
|
Gastrointestinal disorders
Dysphagia
|
3.4%
1/29 • Number of events 1 • From time of consent through +180 days post transplant
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.4%
1/29 • Number of events 1 • From time of consent through +180 days post transplant
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea on Exertion
|
3.4%
1/29 • Number of events 1 • From time of consent through +180 days post transplant
|
|
Renal and urinary disorders
Dysuria
|
3.4%
1/29 • Number of events 1 • From time of consent through +180 days post transplant
|
|
Metabolism and nutrition disorders
Early Satiety
|
3.4%
1/29 • Number of events 1 • From time of consent through +180 days post transplant
|
|
General disorders
Edema BLE
|
3.4%
1/29 • Number of events 1 • From time of consent through +180 days post transplant
|
|
Infections and infestations
Epstein-Barr Virus
|
3.4%
1/29 • Number of events 1 • From time of consent through +180 days post transplant
|
|
Skin and subcutaneous tissue disorders
Erythema
|
3.4%
1/29 • Number of events 1 • From time of consent through +180 days post transplant
|
|
Skin and subcutaneous tissue disorders
Erythroderma
|
3.4%
1/29 • Number of events 1 • From time of consent through +180 days post transplant
|
|
General disorders
Fatigue
|
10.3%
3/29 • Number of events 3 • From time of consent through +180 days post transplant
|
|
General disorders
Fever
|
6.9%
2/29 • Number of events 2 • From time of consent through +180 days post transplant
|
|
Gastrointestinal disorders
Flatulence
|
3.4%
1/29 • Number of events 1 • From time of consent through +180 days post transplant
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
3.4%
1/29 • Number of events 1 • From time of consent through +180 days post transplant
|
|
Musculoskeletal and connective tissue disorders
Generalized Weakness
|
6.9%
2/29 • Number of events 2 • From time of consent through +180 days post transplant
|
|
Immune system disorders
GVHD (GI)
|
10.3%
3/29 • Number of events 3 • From time of consent through +180 days post transplant
|
|
Immune system disorders
GVHD (Liver)
|
6.9%
2/29 • Number of events 2 • From time of consent through +180 days post transplant
|
|
Immune system disorders
GVHD (Oral)
|
3.4%
1/29 • Number of events 2 • From time of consent through +180 days post transplant
|
|
Immune system disorders
GVHD (Skin)
|
17.2%
5/29 • Number of events 6 • From time of consent through +180 days post transplant
|
|
Immune system disorders
GVHD (Skin/Liver)
|
3.4%
1/29 • Number of events 1 • From time of consent through +180 days post transplant
|
|
Infections and infestations
H Pylori
|
3.4%
1/29 • Number of events 1 • From time of consent through +180 days post transplant
|
|
Renal and urinary disorders
Hemorrhagic cystitis
|
3.4%
1/29 • Number of events 1 • From time of consent through +180 days post transplant
|
|
Investigations
Hyperbilirubinemia
|
3.4%
1/29 • Number of events 1 • From time of consent through +180 days post transplant
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
3.4%
1/29 • Number of events 1 • From time of consent through +180 days post transplant
|
|
Metabolism and nutrition disorders
Hyperglycemia (Intermittent)
|
3.4%
1/29 • Number of events 1 • From time of consent through +180 days post transplant
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
3.4%
1/29 • Number of events 1 • From time of consent through +180 days post transplant
|
|
Vascular disorders
Hypertension
|
6.9%
2/29 • Number of events 2 • From time of consent through +180 days post transplant
|
|
Vascular disorders
Hypertension (Intermittent)
|
3.4%
1/29 • Number of events 1 • From time of consent through +180 days post transplant
|
|
Metabolism and nutrition disorders
Hypoglycemia (intermittent)
|
3.4%
1/29 • Number of events 1 • From time of consent through +180 days post transplant
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
3.4%
1/29 • Number of events 1 • From time of consent through +180 days post transplant
|
|
Vascular disorders
Hypotension
|
41.4%
12/29 • Number of events 16 • From time of consent through +180 days post transplant
|
|
Infections and infestations
Infection (Kidney)
|
3.4%
1/29 • Number of events 1 • From time of consent through +180 days post transplant
|
|
Infections and infestations
Infection/Infestation
|
3.4%
1/29 • Number of events 1 • From time of consent through +180 days post transplant
|
|
Infections and infestations
Influenza
|
3.4%
1/29 • Number of events 1 • From time of consent through +180 days post transplant
|
|
Psychiatric disorders
Insomnia
|
3.4%
1/29 • Number of events 1 • From time of consent through +180 days post transplant
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal mucositis
|
3.4%
1/29 • Number of events 1 • From time of consent through +180 days post transplant
|
|
Nervous system disorders
Lethargy
|
3.4%
1/29 • Number of events 1 • From time of consent through +180 days post transplant
|
|
General disorders
Malaise
|
3.4%
1/29 • Number of events 1 • From time of consent through +180 days post transplant
|
|
Gastrointestinal disorders
Mucositis
|
17.2%
5/29 • Number of events 5 • From time of consent through +180 days post transplant
|
|
Gastrointestinal disorders
Nausea
|
20.7%
6/29 • Number of events 7 • From time of consent through +180 days post transplant
|
|
Gastrointestinal disorders
Nausea (Intermittent)
|
6.9%
2/29 • Number of events 2 • From time of consent through +180 days post transplant
|
|
Investigations
Neutrophil Count Decreased
|
3.4%
1/29 • Number of events 2 • From time of consent through +180 days post transplant
|
|
Renal and urinary disorders
Nocturia
|
3.4%
1/29 • Number of events 1 • From time of consent through +180 days post transplant
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
13.8%
4/29 • Number of events 4 • From time of consent through +180 days post transplant
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.9%
2/29 • Number of events 2 • From time of consent through +180 days post transplant
|
|
Skin and subcutaneous tissue disorders
Rash (Erythematous)
|
3.4%
1/29 • Number of events 2 • From time of consent through +180 days post transplant
|
|
Skin and subcutaneous tissue disorders
Rash on Upper Back
|
3.4%
1/29 • Number of events 1 • From time of consent through +180 days post transplant
|
|
Infections and infestations
Respiratory infection (HAP)
|
3.4%
1/29 • Number of events 1 • From time of consent through +180 days post transplant
|
|
Musculoskeletal and connective tissue disorders
Right lower quadrant pain
|
3.4%
1/29 • Number of events 1 • From time of consent through +180 days post transplant
|
|
Skin and subcutaneous tissue disorders
Sacral Decub
|
3.4%
1/29 • Number of events 1 • From time of consent through +180 days post transplant
|
|
Infections and infestations
Streptococcus mitis
|
10.3%
3/29 • Number of events 3 • From time of consent through +180 days post transplant
|
|
General disorders
Swelling R knee
|
3.4%
1/29 • Number of events 1 • From time of consent through +180 days post transplant
|
|
Nervous system disorders
Syncope
|
3.4%
1/29 • Number of events 1 • From time of consent through +180 days post transplant
|
|
Renal and urinary disorders
Urinary frequency
|
10.3%
3/29 • Number of events 3 • From time of consent through +180 days post transplant
|
|
Infections and infestations
Vaginal abscess
|
3.4%
1/29 • Number of events 1 • From time of consent through +180 days post transplant
|
|
Gastrointestinal disorders
Vomiting
|
20.7%
6/29 • Number of events 7 • From time of consent through +180 days post transplant
|
|
Musculoskeletal and connective tissue disorders
Weakness
|
3.4%
1/29 • Number of events 1 • From time of consent through +180 days post transplant
|
|
Investigations
Weight Loss
|
3.4%
1/29 • Number of events 1 • From time of consent through +180 days post transplant
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place