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

Information source: Hackensack University Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: GVHD

Intervention: Telmisartan (Drug)

Phase: N/A

Status: Not yet recruiting

Sponsored by: Hackensack University Medical Center

Official(s) and/or principal investigator(s):
David Schwartz, MD. PhD, Principal Investigator, Affiliation: Hackensack University Medical Center

Overall contact:
David Schwartz, MD, PhD, Email: dschwartz@fastmail.fm

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.

Clinical Details

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

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Number of subjects with grade 3 or greater acute graft vs. host disease (GVHD) in patients receiving allogeneic HCT.

Secondary outcome: Number of subjects with Grade III-IV hypotension as per the National Cancer Institute's Common Terminology

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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 <3 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.

Locations and Contacts

David Schwartz, MD, PhD, Email: dschwartz@fastmail.fm

Hackensack University Medical Center, Hackensack, New Jersey 07601, United States; Not yet recruiting
Additional Information

Starting date: August 2015
Last updated: August 20, 2015

Page last updated: August 23, 2015

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