GVHD
Conditions
Brief summary
This is single-center, open-label, prospective study of telmisartan for the prevention of acute GVHD in approximately 60 subjects undergoing allogeneic HCT for treatment of a hematologic malignancy.
Detailed description
This is single-center, open-label, prospective study of telmisartan for the prevention of acute GVHD in approximately 60 subjects undergoing allogeneic HCT for treatment of a hematologic malignancy. Subjects will receive 160 mg Micardis brand telmisartan once daily, starting 2 days prior to HCT (day -2). Once the patient is discharged post-HCT, treatment will continue through Day +98 post-HCT for a total of 101 days. After treatment discontinuation on or before day +98 post-HCT, subjects will be followed for up to 6 months for primary and secondary endpoints.
Interventions
DRUGTelmisartan
Sponsors
Hackensack Meridian Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of: * Acute myeloid or lymphoid leukemia in remission, * Myelodysplastic syndrome, * Chronic lymphoid leukemia, * Non-Hodgkin lymphoma, * Hodgkin lymphoma, * Chronic myeloid leukemia in chronic or accelerated phase, * Myeloproliferative disorder, or * Multiple myeloma * Undergoing allogeneic HSC transplantation from a related or unrelated donor matched at least at 7 of 8 of the HLA-A, -B, -C, and DR loci ("8/8" or "7/8" match) * Undergoing allogeneic HSC transplantation after a myeloablative TBI-, busulfan-, or (non-myeloablative) melphalan-based pre-transplant conditioning regimen. Regimens for transplantation will include at one of the following agents, given in conjunction with fludarabine or cyclophosphamide: * Busulfan 130 mg/m2 iv daily x 2 (reduced intensity) or 4 days * TBI 150 cGy bid x8 doses (1200 Gy) * Melphalan 140 mg/m2. (Although melphalan is not a myeloablative regimen, it results in clinically significant mucositis and patients receiving this medication will be of considerable interest in the analysis of these data.) * Male or female patient age 18 years or older * Karnofsky performance status \> 70% at time of initiation of pre-transplant conditioning * Transplantation-specific co-morbidity score of \<5 at time of initiation of pre-transplant conditioning * Patients taking antihypertensive medications (including telmisartan) are eligible but the patient must discontinue treatment at least 48 hours prior to first dose of study medication * Capable of giving informed consent and having signed the informed consent form
Exclusion criteria
* Inability to provide informed consent * Subjects with known heart failure, advanced renal impairment requiring renal replacement therapy, or liver failure although these patients would most likely not be eligible for HCT. * Subjects taking ACE inhibitors, potassium supplements, or spironolactone (or any other potassium-sparing diuretics) who cannot discontinue use prior to initiation of study treatment OR who require a high-potassium diet * Patient unable to discontinue current hypertension medication for medical or other reasons for two days prior to starting telmisartan * Chronic symptomatic hypotension, volume depletion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Subjects With Grade 3 or Greater Acute Graft vs. Host Disease (GVHD) in Patients Receiving Allogeneic HCT. | 100 days post-transplant |
Secondary
| Measure | Time frame |
|---|---|
| Number of Subjects With Grade III-IV Hypotension as Per the National Cancer Institute's Common Terminology | 180 days post- transplant |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORScott Rowley, MD
Hackensack Meridian Health
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 160 mg Telmisartan 60 patients will receive 160 of Telmisartan (2 80 mg tablets) for 101 days
Telmisartan | 29 |
| Total | 29 |
Baseline characteristics
| Characteristic | 160 mg Telmisartan |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 5 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants |
| Age, Continuous | 54.33 Years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 25 Participants |
| Region of Enrollment United States | 29 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 6 / 29 |
| other Total, other adverse events | 24 / 29 |
| serious Total, serious adverse events | 8 / 29 |
Outcome results
Primary
Number of Subjects With Grade 3 or Greater Acute Graft vs. Host Disease (GVHD) in Patients Receiving Allogeneic HCT.
Time frame: 100 days post-transplant
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 160 mg Telmisartan | Number of Subjects With Grade 3 or Greater Acute Graft vs. Host Disease (GVHD) in Patients Receiving Allogeneic HCT. | 1 Participants |
Secondary
Number of Subjects With Grade III-IV Hypotension as Per the National Cancer Institute's Common Terminology
Time frame: 180 days post- transplant
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 160 mg Telmisartan | Number of Subjects With Grade III-IV Hypotension as Per the National Cancer Institute's Common Terminology | 6 Participants |