Study of TelmisartanFor the Prevention of Acute GVHD Post Allogeneic Hematopoietic Stem Cell Transplantation
- Registration Number
- NCT02338232
- Lead Sponsor
- Hackensack Meridian Health
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 32
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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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 160 mg Telmisartan Telmisartan 60 patients will receive 160 of Telmisartan (2 80 mg tablets) for 101 days
- Primary Outcome Measures
Name Time Method Number of Subjects With Grade 3 or Greater Acute Graft vs. Host Disease (GVHD) in Patients Receiving Allogeneic HCT. 100 days post-transplant
- Secondary Outcome Measures
Name Time Method Number of Subjects With Grade III-IV Hypotension as Per the National Cancer Institute's Common Terminology 180 days post- transplant
Trial Locations
- Locations (1)
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States