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

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.

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.