Study of TelmisartanFor the Prevention of Acute GVHD Post Allogeneic Hematopoietic Stem Cell Transplantation
Stopped early · Not applicable
Conditions studied: GVHD
In brief
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.
Key facts
- Study ID
- NCT02338232
- Run by
- Hackensack Meridian Health
- People needed
- 32
- Starts
- 2015-07-07
- Expected to finish
- 2023-01-05
- Last updated by the study team
- 2026-04-02
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Hackensack University Medical Center — Hackensack, New Jersey, United States
Full record on ClinicalTrials.gov
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