Study of TelmisartanFor the Prevention of Acute GVHD Post Allogeneic Hematopoietic Stem Cell Transplantation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pilot Study of Telmisartan (Micardis) For the Prevention of Acute Graft vs. Host Disease Post Allogeneic Hematopoietic Stem Cell Transplantation

Conditions
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GVHD

Intervention / Treatment
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* Drug: Telmisartan


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 160 mg Telmisartan<br>60 patients will receive 160 of Telmisartan (2 80 mg tablets) for 101 days | Drug: Telmisartan<br> <br> * Other names: Micardis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with Grade III-IV hypotension as per the National Cancer Institute's Common Terminology |  | 180 days post- transplant |